AACE 2011

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.

"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.

Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).

The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.

Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.

Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.

The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.

The study was supported by AstraZeneca.

SAN DIEGO – Contrary to conventional wisdom, primary hyperparathyroidism is not extremely rare among people younger than 30 years, and it presents differently in these patients, compared with those older than 60 years, according to an analysis of data from 335 consecutive patients.

"Since routine calcium screening is not done in younger patients, primary hyperparathyroidism should be considered when nephrolithiasis, GERD [gastroesophageal reflux disease], and bone disease occur in patients younger than 30 years," Dr. Jovenel Cherenfant of the University of Chicago and his colleagues concluded.

To identify differences in hyperparathyroidism among age groups, the researchers reviewed data from 335 consecutive patients who underwent parathyroidectomy at a single center between 1998 and 2009.

The study population included 40 patients younger than 30 years, 155 patients aged 30-60 years, and 140 patients older than 60 years. Approximately 63% were women.

Prior to surgery, calcium and parathyroid hormone levels were significantly higher in patients younger than 30 years, compared with those older than 60 years. Presurgical calcium levels in patients younger than 30 years and those older than 60 years were 11.7 mg/dL and 10.9 mg/dL, respectively. Presurgical parathyroid hormone levels for the older and younger groups were 290 pg/mL and 159 pg/mL, respectively. All levels returned to normal after surgery; the median postoperative calcium and intact parathyroid hormone values for all patients were 9.35 mg/dL and 42.1 pg/mL, respectively, according to the results, which were presented in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

At presentation, 58% of patients younger than 30 years complained of GERD, compared with 26% of those aged 30-60 years and 23% of those older than 60 years.

After the researchers controlled for age, women had a higher prevalence of GERD and osteoporosis, compared with men. Men of all ages were more likely to have a history of kidney stones, compared with women, but kidney stones were more common in younger women, compared with older women (40% of women younger than 30 years vs. 12% of women older than 30 years).

In addition, osteoporosis was significantly more common in patients older than 60 years vs. those younger than 30 years (49% vs. 9%), but 63% of the younger women had osteopenia, vs. 43% of those older than 60 years.

Dr. Cherenfant had no financial conflicts to disclose.

SAN DIEGO – Contrary to conventional wisdom, primary hyperparathyroidism is not extremely rare among people younger than 30 years, and it presents differently in these patients, compared with those older than 60 years, according to an analysis of data from 335 consecutive patients.

"Since routine calcium screening is not done in younger patients, primary hyperparathyroidism should be considered when nephrolithiasis, GERD [gastroesophageal reflux disease], and bone disease occur in patients younger than 30 years," Dr. Jovenel Cherenfant of the University of Chicago and his colleagues concluded.

To identify differences in hyperparathyroidism among age groups, the researchers reviewed data from 335 consecutive patients who underwent parathyroidectomy at a single center between 1998 and 2009.

The study population included 40 patients younger than 30 years, 155 patients aged 30-60 years, and 140 patients older than 60 years. Approximately 63% were women.

Prior to surgery, calcium and parathyroid hormone levels were significantly higher in patients younger than 30 years, compared with those older than 60 years. Presurgical calcium levels in patients younger than 30 years and those older than 60 years were 11.7 mg/dL and 10.9 mg/dL, respectively. Presurgical parathyroid hormone levels for the older and younger groups were 290 pg/mL and 159 pg/mL, respectively. All levels returned to normal after surgery; the median postoperative calcium and intact parathyroid hormone values for all patients were 9.35 mg/dL and 42.1 pg/mL, respectively, according to the results, which were presented in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

At presentation, 58% of patients younger than 30 years complained of GERD, compared with 26% of those aged 30-60 years and 23% of those older than 60 years.

After the researchers controlled for age, women had a higher prevalence of GERD and osteoporosis, compared with men. Men of all ages were more likely to have a history of kidney stones, compared with women, but kidney stones were more common in younger women, compared with older women (40% of women younger than 30 years vs. 12% of women older than 30 years).

In addition, osteoporosis was significantly more common in patients older than 60 years vs. those younger than 30 years (49% vs. 9%), but 63% of the younger women had osteopenia, vs. 43% of those older than 60 years.

Dr. Cherenfant had no financial conflicts to disclose.

SAN DIEGO – Contrary to conventional wisdom, primary hyperparathyroidism is not extremely rare among people younger than 30 years, and it presents differently in these patients, compared with those older than 60 years, according to an analysis of data from 335 consecutive patients.

"Since routine calcium screening is not done in younger patients, primary hyperparathyroidism should be considered when nephrolithiasis, GERD [gastroesophageal reflux disease], and bone disease occur in patients younger than 30 years," Dr. Jovenel Cherenfant of the University of Chicago and his colleagues concluded.

To identify differences in hyperparathyroidism among age groups, the researchers reviewed data from 335 consecutive patients who underwent parathyroidectomy at a single center between 1998 and 2009.

The study population included 40 patients younger than 30 years, 155 patients aged 30-60 years, and 140 patients older than 60 years. Approximately 63% were women.

Prior to surgery, calcium and parathyroid hormone levels were significantly higher in patients younger than 30 years, compared with those older than 60 years. Presurgical calcium levels in patients younger than 30 years and those older than 60 years were 11.7 mg/dL and 10.9 mg/dL, respectively. Presurgical parathyroid hormone levels for the older and younger groups were 290 pg/mL and 159 pg/mL, respectively. All levels returned to normal after surgery; the median postoperative calcium and intact parathyroid hormone values for all patients were 9.35 mg/dL and 42.1 pg/mL, respectively, according to the results, which were presented in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

At presentation, 58% of patients younger than 30 years complained of GERD, compared with 26% of those aged 30-60 years and 23% of those older than 60 years.

After the researchers controlled for age, women had a higher prevalence of GERD and osteoporosis, compared with men. Men of all ages were more likely to have a history of kidney stones, compared with women, but kidney stones were more common in younger women, compared with older women (40% of women younger than 30 years vs. 12% of women older than 30 years).

In addition, osteoporosis was significantly more common in patients older than 60 years vs. those younger than 30 years (49% vs. 9%), but 63% of the younger women had osteopenia, vs. 43% of those older than 60 years.

Dr. Cherenfant had no financial conflicts to disclose.

SAN DIEGO – Contrary to conventional wisdom, primary hyperparathyroidism is not extremely rare among people younger than 30 years, and it presents differently in these patients, compared with those older than 60 years, according to an analysis of data from 335 consecutive patients.

"Since routine calcium screening is not done in younger patients, primary hyperparathyroidism should be considered when nephrolithiasis, GERD [gastroesophageal reflux disease], and bone disease occur in patients younger than 30 years," Dr. Jovenel Cherenfant of the University of Chicago and his colleagues concluded.

To identify differences in hyperparathyroidism among age groups, the researchers reviewed data from 335 consecutive patients who underwent parathyroidectomy at a single center between 1998 and 2009.

The study population included 40 patients younger than 30 years, 155 patients aged 30-60 years, and 140 patients older than 60 years. Approximately 63% were women.

Prior to surgery, calcium and parathyroid hormone levels were significantly higher in patients younger than 30 years, compared with those older than 60 years. Presurgical calcium levels in patients younger than 30 years and those older than 60 years were 11.7 mg/dL and 10.9 mg/dL, respectively. Presurgical parathyroid hormone levels for the older and younger groups were 290 pg/mL and 159 pg/mL, respectively. All levels returned to normal after surgery; the median postoperative calcium and intact parathyroid hormone values for all patients were 9.35 mg/dL and 42.1 pg/mL, respectively, according to the results, which were presented in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

At presentation, 58% of patients younger than 30 years complained of GERD, compared with 26% of those aged 30-60 years and 23% of those older than 60 years.

After the researchers controlled for age, women had a higher prevalence of GERD and osteoporosis, compared with men. Men of all ages were more likely to have a history of kidney stones, compared with women, but kidney stones were more common in younger women, compared with older women (40% of women younger than 30 years vs. 12% of women older than 30 years).

In addition, osteoporosis was significantly more common in patients older than 60 years vs. those younger than 30 years (49% vs. 9%), but 63% of the younger women had osteopenia, vs. 43% of those older than 60 years.

Dr. Cherenfant had no financial conflicts to disclose.

SAN DIEGO – Contrary to conventional wisdom, primary hyperparathyroidism is not extremely rare among people younger than 30 years, and it presents differently in these patients, compared with those older than 60 years, according to an analysis of data from 335 consecutive patients.

"Since routine calcium screening is not done in younger patients, primary hyperparathyroidism should be considered when nephrolithiasis, GERD [gastroesophageal reflux disease], and bone disease occur in patients younger than 30 years," Dr. Jovenel Cherenfant of the University of Chicago and his colleagues concluded.

To identify differences in hyperparathyroidism among age groups, the researchers reviewed data from 335 consecutive patients who underwent parathyroidectomy at a single center between 1998 and 2009.

The study population included 40 patients younger than 30 years, 155 patients aged 30-60 years, and 140 patients older than 60 years. Approximately 63% were women.

Prior to surgery, calcium and parathyroid hormone levels were significantly higher in patients younger than 30 years, compared with those older than 60 years. Presurgical calcium levels in patients younger than 30 years and those older than 60 years were 11.7 mg/dL and 10.9 mg/dL, respectively. Presurgical parathyroid hormone levels for the older and younger groups were 290 pg/mL and 159 pg/mL, respectively. All levels returned to normal after surgery; the median postoperative calcium and intact parathyroid hormone values for all patients were 9.35 mg/dL and 42.1 pg/mL, respectively, according to the results, which were presented in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

At presentation, 58% of patients younger than 30 years complained of GERD, compared with 26% of those aged 30-60 years and 23% of those older than 60 years.

After the researchers controlled for age, women had a higher prevalence of GERD and osteoporosis, compared with men. Men of all ages were more likely to have a history of kidney stones, compared with women, but kidney stones were more common in younger women, compared with older women (40% of women younger than 30 years vs. 12% of women older than 30 years).

In addition, osteoporosis was significantly more common in patients older than 60 years vs. those younger than 30 years (49% vs. 9%), but 63% of the younger women had osteopenia, vs. 43% of those older than 60 years.

Dr. Cherenfant had no financial conflicts to disclose.

SAN DIEGO – Contrary to conventional wisdom, primary hyperparathyroidism is not extremely rare among people younger than 30 years, and it presents differently in these patients, compared with those older than 60 years, according to an analysis of data from 335 consecutive patients.

"Since routine calcium screening is not done in younger patients, primary hyperparathyroidism should be considered when nephrolithiasis, GERD [gastroesophageal reflux disease], and bone disease occur in patients younger than 30 years," Dr. Jovenel Cherenfant of the University of Chicago and his colleagues concluded.

To identify differences in hyperparathyroidism among age groups, the researchers reviewed data from 335 consecutive patients who underwent parathyroidectomy at a single center between 1998 and 2009.

The study population included 40 patients younger than 30 years, 155 patients aged 30-60 years, and 140 patients older than 60 years. Approximately 63% were women.

Prior to surgery, calcium and parathyroid hormone levels were significantly higher in patients younger than 30 years, compared with those older than 60 years. Presurgical calcium levels in patients younger than 30 years and those older than 60 years were 11.7 mg/dL and 10.9 mg/dL, respectively. Presurgical parathyroid hormone levels for the older and younger groups were 290 pg/mL and 159 pg/mL, respectively. All levels returned to normal after surgery; the median postoperative calcium and intact parathyroid hormone values for all patients were 9.35 mg/dL and 42.1 pg/mL, respectively, according to the results, which were presented in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

At presentation, 58% of patients younger than 30 years complained of GERD, compared with 26% of those aged 30-60 years and 23% of those older than 60 years.

After the researchers controlled for age, women had a higher prevalence of GERD and osteoporosis, compared with men. Men of all ages were more likely to have a history of kidney stones, compared with women, but kidney stones were more common in younger women, compared with older women (40% of women younger than 30 years vs. 12% of women older than 30 years).

In addition, osteoporosis was significantly more common in patients older than 60 years vs. those younger than 30 years (49% vs. 9%), but 63% of the younger women had osteopenia, vs. 43% of those older than 60 years.

Dr. Cherenfant had no financial conflicts to disclose.

SAN DIEGO – Type 2 diabetes patients treated with linagliptin showed statistically significant improvements in hemoglobin A_1c level after 24 weeks, regardless of their body mass index, on the basis of data from a pooled analysis of 2,224 patients.

Linagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, was approved by the U.S. Food and Drug Administration on May 2 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Two other DPP-4 inhibitors have been previously approved for the same indication – sitagliptin (Januvia) and saxagliptin (Onglyza).

In three phase III, randomized, double-blind, placebo-controlled trials, the primary efficacy outcome was the change in HbA_1c level from baseline to 24 weeks. The average reduction in HbA_1c was similar between BMI groups: –0.79 for those with a BMI less than 25 kg/m², –0.57 for those with a BMI of 25-30, and –0.62 for those with a BMI above 30, Dr. Angelina Trujillo of Boehringer Ingelheim Pharmaceuticals in Ridgefield, Conn., reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

One study evaluated linagliptin as monotherapy in patients previously untreated with oral diabetes medications or taking a single nonthiazolidinedione medication. The second study evaluated linagliptin when added to metformin in patients whose diabetes was not well controlled, some of whom were taking one additional oral antidiabetic medication. The third study evaluated linagliptin as additional therapy for patients whose diabetes was not well controlled on both metformin and a sulfonylurea.

The mean age of the patients ranged from 55 to 58 years, and about half were women. The average BMI ranged from 23 to 34 kg/m².

The overall rate of adverse events was similar among the three groups, Dr. Trujillo and her associates found. In particular, the overall incidence of hyperglycemia was lower in the linagliptin group, compared with the placebo group, across all BMI categories. A higher incidence of hypoglycemia in the linagliptin group compared with the placebo group was seen in the linagliptin patients who were taking both metformin and a sulfonylurea.

"This was expected, as previously described in the literature, due to the combination with a sulfonylurea," she wrote in the poster. "The overall hypoglycemic event rate with linagliptin in monotherapy and add-on to metformin therapy was very low (less than 1.0%)," she added.

The incidence of serious adverse events based on BMI categories in the linagliptin and placebo groups were 4% and 5%, respectively, in those with BMIs of less than 25 kg/m²; 3% and 4% in those with BMIs of 25-30 kg/m²; and 3% and 2% in those with BMIs above 30.

"The safety and tolerability of linagliptin was comparable to placebo across baseline categories of normal, overweight, and obese BMI in this pooled analysis," she reported.

Litagliptin will be marketed as Tradjenta by Boehringer Ingelheim Pharmaceuticals and Eli Lilly. The study was supported by Boehringer Ingelheim Pharmaceuticals.

SAN DIEGO – Type 2 diabetes patients treated with linagliptin showed statistically significant improvements in hemoglobin A_1c level after 24 weeks, regardless of their body mass index, on the basis of data from a pooled analysis of 2,224 patients.

Linagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, was approved by the U.S. Food and Drug Administration on May 2 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Two other DPP-4 inhibitors have been previously approved for the same indication – sitagliptin (Januvia) and saxagliptin (Onglyza).

In three phase III, randomized, double-blind, placebo-controlled trials, the primary efficacy outcome was the change in HbA_1c level from baseline to 24 weeks. The average reduction in HbA_1c was similar between BMI groups: –0.79 for those with a BMI less than 25 kg/m², –0.57 for those with a BMI of 25-30, and –0.62 for those with a BMI above 30, Dr. Angelina Trujillo of Boehringer Ingelheim Pharmaceuticals in Ridgefield, Conn., reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

One study evaluated linagliptin as monotherapy in patients previously untreated with oral diabetes medications or taking a single nonthiazolidinedione medication. The second study evaluated linagliptin when added to metformin in patients whose diabetes was not well controlled, some of whom were taking one additional oral antidiabetic medication. The third study evaluated linagliptin as additional therapy for patients whose diabetes was not well controlled on both metformin and a sulfonylurea.

The mean age of the patients ranged from 55 to 58 years, and about half were women. The average BMI ranged from 23 to 34 kg/m².

The overall rate of adverse events was similar among the three groups, Dr. Trujillo and her associates found. In particular, the overall incidence of hyperglycemia was lower in the linagliptin group, compared with the placebo group, across all BMI categories. A higher incidence of hypoglycemia in the linagliptin group compared with the placebo group was seen in the linagliptin patients who were taking both metformin and a sulfonylurea.

"This was expected, as previously described in the literature, due to the combination with a sulfonylurea," she wrote in the poster. "The overall hypoglycemic event rate with linagliptin in monotherapy and add-on to metformin therapy was very low (less than 1.0%)," she added.

The incidence of serious adverse events based on BMI categories in the linagliptin and placebo groups were 4% and 5%, respectively, in those with BMIs of less than 25 kg/m²; 3% and 4% in those with BMIs of 25-30 kg/m²; and 3% and 2% in those with BMIs above 30.

"The safety and tolerability of linagliptin was comparable to placebo across baseline categories of normal, overweight, and obese BMI in this pooled analysis," she reported.

Litagliptin will be marketed as Tradjenta by Boehringer Ingelheim Pharmaceuticals and Eli Lilly. The study was supported by Boehringer Ingelheim Pharmaceuticals.

SAN DIEGO – Type 2 diabetes patients treated with linagliptin showed statistically significant improvements in hemoglobin A_1c level after 24 weeks, regardless of their body mass index, on the basis of data from a pooled analysis of 2,224 patients.

Linagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, was approved by the U.S. Food and Drug Administration on May 2 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Two other DPP-4 inhibitors have been previously approved for the same indication – sitagliptin (Januvia) and saxagliptin (Onglyza).

In three phase III, randomized, double-blind, placebo-controlled trials, the primary efficacy outcome was the change in HbA_1c level from baseline to 24 weeks. The average reduction in HbA_1c was similar between BMI groups: –0.79 for those with a BMI less than 25 kg/m², –0.57 for those with a BMI of 25-30, and –0.62 for those with a BMI above 30, Dr. Angelina Trujillo of Boehringer Ingelheim Pharmaceuticals in Ridgefield, Conn., reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

One study evaluated linagliptin as monotherapy in patients previously untreated with oral diabetes medications or taking a single nonthiazolidinedione medication. The second study evaluated linagliptin when added to metformin in patients whose diabetes was not well controlled, some of whom were taking one additional oral antidiabetic medication. The third study evaluated linagliptin as additional therapy for patients whose diabetes was not well controlled on both metformin and a sulfonylurea.

The mean age of the patients ranged from 55 to 58 years, and about half were women. The average BMI ranged from 23 to 34 kg/m².

The overall rate of adverse events was similar among the three groups, Dr. Trujillo and her associates found. In particular, the overall incidence of hyperglycemia was lower in the linagliptin group, compared with the placebo group, across all BMI categories. A higher incidence of hypoglycemia in the linagliptin group compared with the placebo group was seen in the linagliptin patients who were taking both metformin and a sulfonylurea.

"This was expected, as previously described in the literature, due to the combination with a sulfonylurea," she wrote in the poster. "The overall hypoglycemic event rate with linagliptin in monotherapy and add-on to metformin therapy was very low (less than 1.0%)," she added.

The incidence of serious adverse events based on BMI categories in the linagliptin and placebo groups were 4% and 5%, respectively, in those with BMIs of less than 25 kg/m²; 3% and 4% in those with BMIs of 25-30 kg/m²; and 3% and 2% in those with BMIs above 30.

"The safety and tolerability of linagliptin was comparable to placebo across baseline categories of normal, overweight, and obese BMI in this pooled analysis," she reported.

Litagliptin will be marketed as Tradjenta by Boehringer Ingelheim Pharmaceuticals and Eli Lilly. The study was supported by Boehringer Ingelheim Pharmaceuticals.

SAN DIEGO – Type 2 diabetes patients treated with linagliptin showed statistically significant improvements in hemoglobin A_1c level after 24 weeks, regardless of their body mass index, on the basis of data from a pooled analysis of 2,224 patients.

Linagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, was approved by the U.S. Food and Drug Administration on May 2 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Two other DPP-4 inhibitors have been previously approved for the same indication – sitagliptin (Januvia) and saxagliptin (Onglyza).

In three phase III, randomized, double-blind, placebo-controlled trials, the primary efficacy outcome was the change in HbA_1c level from baseline to 24 weeks. The average reduction in HbA_1c was similar between BMI groups: –0.79 for those with a BMI less than 25 kg/m², –0.57 for those with a BMI of 25-30, and –0.62 for those with a BMI above 30, Dr. Angelina Trujillo of Boehringer Ingelheim Pharmaceuticals in Ridgefield, Conn., reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

One study evaluated linagliptin as monotherapy in patients previously untreated with oral diabetes medications or taking a single nonthiazolidinedione medication. The second study evaluated linagliptin when added to metformin in patients whose diabetes was not well controlled, some of whom were taking one additional oral antidiabetic medication. The third study evaluated linagliptin as additional therapy for patients whose diabetes was not well controlled on both metformin and a sulfonylurea.

The mean age of the patients ranged from 55 to 58 years, and about half were women. The average BMI ranged from 23 to 34 kg/m².

The overall rate of adverse events was similar among the three groups, Dr. Trujillo and her associates found. In particular, the overall incidence of hyperglycemia was lower in the linagliptin group, compared with the placebo group, across all BMI categories. A higher incidence of hypoglycemia in the linagliptin group compared with the placebo group was seen in the linagliptin patients who were taking both metformin and a sulfonylurea.

"This was expected, as previously described in the literature, due to the combination with a sulfonylurea," she wrote in the poster. "The overall hypoglycemic event rate with linagliptin in monotherapy and add-on to metformin therapy was very low (less than 1.0%)," she added.

The incidence of serious adverse events based on BMI categories in the linagliptin and placebo groups were 4% and 5%, respectively, in those with BMIs of less than 25 kg/m²; 3% and 4% in those with BMIs of 25-30 kg/m²; and 3% and 2% in those with BMIs above 30.

"The safety and tolerability of linagliptin was comparable to placebo across baseline categories of normal, overweight, and obese BMI in this pooled analysis," she reported.

Litagliptin will be marketed as Tradjenta by Boehringer Ingelheim Pharmaceuticals and Eli Lilly. The study was supported by Boehringer Ingelheim Pharmaceuticals.

SAN DIEGO – Type 2 diabetes patients treated with linagliptin showed statistically significant improvements in hemoglobin A_1c level after 24 weeks, regardless of their body mass index, on the basis of data from a pooled analysis of 2,224 patients.

Linagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, was approved by the U.S. Food and Drug Administration on May 2 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Two other DPP-4 inhibitors have been previously approved for the same indication – sitagliptin (Januvia) and saxagliptin (Onglyza).

In three phase III, randomized, double-blind, placebo-controlled trials, the primary efficacy outcome was the change in HbA_1c level from baseline to 24 weeks. The average reduction in HbA_1c was similar between BMI groups: –0.79 for those with a BMI less than 25 kg/m², –0.57 for those with a BMI of 25-30, and –0.62 for those with a BMI above 30, Dr. Angelina Trujillo of Boehringer Ingelheim Pharmaceuticals in Ridgefield, Conn., reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

One study evaluated linagliptin as monotherapy in patients previously untreated with oral diabetes medications or taking a single nonthiazolidinedione medication. The second study evaluated linagliptin when added to metformin in patients whose diabetes was not well controlled, some of whom were taking one additional oral antidiabetic medication. The third study evaluated linagliptin as additional therapy for patients whose diabetes was not well controlled on both metformin and a sulfonylurea.

The mean age of the patients ranged from 55 to 58 years, and about half were women. The average BMI ranged from 23 to 34 kg/m².

The overall rate of adverse events was similar among the three groups, Dr. Trujillo and her associates found. In particular, the overall incidence of hyperglycemia was lower in the linagliptin group, compared with the placebo group, across all BMI categories. A higher incidence of hypoglycemia in the linagliptin group compared with the placebo group was seen in the linagliptin patients who were taking both metformin and a sulfonylurea.

"This was expected, as previously described in the literature, due to the combination with a sulfonylurea," she wrote in the poster. "The overall hypoglycemic event rate with linagliptin in monotherapy and add-on to metformin therapy was very low (less than 1.0%)," she added.

The incidence of serious adverse events based on BMI categories in the linagliptin and placebo groups were 4% and 5%, respectively, in those with BMIs of less than 25 kg/m²; 3% and 4% in those with BMIs of 25-30 kg/m²; and 3% and 2% in those with BMIs above 30.

"The safety and tolerability of linagliptin was comparable to placebo across baseline categories of normal, overweight, and obese BMI in this pooled analysis," she reported.

Litagliptin will be marketed as Tradjenta by Boehringer Ingelheim Pharmaceuticals and Eli Lilly. The study was supported by Boehringer Ingelheim Pharmaceuticals.

SAN DIEGO – Type 2 diabetes patients treated with linagliptin showed statistically significant improvements in hemoglobin A_1c level after 24 weeks, regardless of their body mass index, on the basis of data from a pooled analysis of 2,224 patients.

Linagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, was approved by the U.S. Food and Drug Administration on May 2 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Two other DPP-4 inhibitors have been previously approved for the same indication – sitagliptin (Januvia) and saxagliptin (Onglyza).

In three phase III, randomized, double-blind, placebo-controlled trials, the primary efficacy outcome was the change in HbA_1c level from baseline to 24 weeks. The average reduction in HbA_1c was similar between BMI groups: –0.79 for those with a BMI less than 25 kg/m², –0.57 for those with a BMI of 25-30, and –0.62 for those with a BMI above 30, Dr. Angelina Trujillo of Boehringer Ingelheim Pharmaceuticals in Ridgefield, Conn., reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

One study evaluated linagliptin as monotherapy in patients previously untreated with oral diabetes medications or taking a single nonthiazolidinedione medication. The second study evaluated linagliptin when added to metformin in patients whose diabetes was not well controlled, some of whom were taking one additional oral antidiabetic medication. The third study evaluated linagliptin as additional therapy for patients whose diabetes was not well controlled on both metformin and a sulfonylurea.

The mean age of the patients ranged from 55 to 58 years, and about half were women. The average BMI ranged from 23 to 34 kg/m².

The overall rate of adverse events was similar among the three groups, Dr. Trujillo and her associates found. In particular, the overall incidence of hyperglycemia was lower in the linagliptin group, compared with the placebo group, across all BMI categories. A higher incidence of hypoglycemia in the linagliptin group compared with the placebo group was seen in the linagliptin patients who were taking both metformin and a sulfonylurea.

"This was expected, as previously described in the literature, due to the combination with a sulfonylurea," she wrote in the poster. "The overall hypoglycemic event rate with linagliptin in monotherapy and add-on to metformin therapy was very low (less than 1.0%)," she added.

The incidence of serious adverse events based on BMI categories in the linagliptin and placebo groups were 4% and 5%, respectively, in those with BMIs of less than 25 kg/m²; 3% and 4% in those with BMIs of 25-30 kg/m²; and 3% and 2% in those with BMIs above 30.

"The safety and tolerability of linagliptin was comparable to placebo across baseline categories of normal, overweight, and obese BMI in this pooled analysis," she reported.

Litagliptin will be marketed as Tradjenta by Boehringer Ingelheim Pharmaceuticals and Eli Lilly. The study was supported by Boehringer Ingelheim Pharmaceuticals.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Women with nontoxic goiter were more than twice as likely to have breast cancer, compared with women in the general population, according to a review of data from 789 women with nontoxic, multinodular goiter, uninodular goiter, or simple goiter.

The findings were presented at the annual meeting of the American Association of Clinical Endocrinologists.

Data from previous studies of a potential link between thyroid disorders and breast cancer are inconclusive, said Sarika Patel Sanghvi, D.O., of Robert Wood Johnson Medical School in New Brunswick, N.J.

In this study, Dr. Sanghvi and her colleagues compared breast cancer incidence in women with nontoxic goiter with breast cancer incidence in the general population of New Jersey. Breast cancer history was obtained from each patient’s medical history.

Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%. By contrast, the prevalence of breast cancer in the general population, based on data from the New Jersey Department of Health and Senior Services, was significantly lower at 1.6%.

Two of the 28 patients with breast cancer had low TSH levels, but one had a free T4 within normal limits and the other had a total T4 within normal limits, said Dr. Sanghvi. Four of the 28 patients had serum thyroid peroxidase (TPO) antibodies, only one level of which was elevated, but this patient had normal TSH and free T4 levels, Dr. Sanghvi said.

The association between breast cancer and nontoxic goiter is unclear, she said. Possible mechanisms include the role of iodine, thyroid-stimulating hormone, and estrogen.

"Iodine has been theorized as being a causative factor, because it is utilized by both breast and thyroid tissues," and these are the only two organs in which iodine is stored. Dr. Sanghvi explained. However, epidemiologic studies are needed to explore the association between iodine and breast cancer, she said.

The results were limited by the retrospective nature of the study, and the lack of a standard medical history questionnaire. But they underscore the important of breast cancer screening in women with benign thyroid disease until larger, prospective studies provide additional information, Dr. Sanghvi said.

In the study population as a whole, the average age was 51 years, the average body mass index was 29.2 kg/m², the average TSH was 2.02 mIU/L, and the average free T4 was 1.67 ng/dL. Among the 28 patients with a family history of breast cancer, the average age was 57 years, the average BMI was 29 kg/m², the average TSH was 1.54 mIU/L, and the average free T4 was 1.14 ng/dL

One of the patients with breast cancer had ductal carcinoma in situ; the breast cancer types in the other 27 patients were not specified.

Dr. Sanghvi reported having no financial conflicts to disclose.

SAN DIEGO – Women with nontoxic goiter were more than twice as likely to have breast cancer, compared with women in the general population, according to a review of data from 789 women with nontoxic, multinodular goiter, uninodular goiter, or simple goiter.

The findings were presented at the annual meeting of the American Association of Clinical Endocrinologists.

Data from previous studies of a potential link between thyroid disorders and breast cancer are inconclusive, said Sarika Patel Sanghvi, D.O., of Robert Wood Johnson Medical School in New Brunswick, N.J.

In this study, Dr. Sanghvi and her colleagues compared breast cancer incidence in women with nontoxic goiter with breast cancer incidence in the general population of New Jersey. Breast cancer history was obtained from each patient’s medical history.

Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%. By contrast, the prevalence of breast cancer in the general population, based on data from the New Jersey Department of Health and Senior Services, was significantly lower at 1.6%.

Two of the 28 patients with breast cancer had low TSH levels, but one had a free T4 within normal limits and the other had a total T4 within normal limits, said Dr. Sanghvi. Four of the 28 patients had serum thyroid peroxidase (TPO) antibodies, only one level of which was elevated, but this patient had normal TSH and free T4 levels, Dr. Sanghvi said.

The association between breast cancer and nontoxic goiter is unclear, she said. Possible mechanisms include the role of iodine, thyroid-stimulating hormone, and estrogen.

"Iodine has been theorized as being a causative factor, because it is utilized by both breast and thyroid tissues," and these are the only two organs in which iodine is stored. Dr. Sanghvi explained. However, epidemiologic studies are needed to explore the association between iodine and breast cancer, she said.

The results were limited by the retrospective nature of the study, and the lack of a standard medical history questionnaire. But they underscore the important of breast cancer screening in women with benign thyroid disease until larger, prospective studies provide additional information, Dr. Sanghvi said.

In the study population as a whole, the average age was 51 years, the average body mass index was 29.2 kg/m², the average TSH was 2.02 mIU/L, and the average free T4 was 1.67 ng/dL. Among the 28 patients with a family history of breast cancer, the average age was 57 years, the average BMI was 29 kg/m², the average TSH was 1.54 mIU/L, and the average free T4 was 1.14 ng/dL

One of the patients with breast cancer had ductal carcinoma in situ; the breast cancer types in the other 27 patients were not specified.

Dr. Sanghvi reported having no financial conflicts to disclose.

SAN DIEGO – Women with nontoxic goiter were more than twice as likely to have breast cancer, compared with women in the general population, according to a review of data from 789 women with nontoxic, multinodular goiter, uninodular goiter, or simple goiter.

The findings were presented at the annual meeting of the American Association of Clinical Endocrinologists.

Data from previous studies of a potential link between thyroid disorders and breast cancer are inconclusive, said Sarika Patel Sanghvi, D.O., of Robert Wood Johnson Medical School in New Brunswick, N.J.

In this study, Dr. Sanghvi and her colleagues compared breast cancer incidence in women with nontoxic goiter with breast cancer incidence in the general population of New Jersey. Breast cancer history was obtained from each patient’s medical history.

Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%. By contrast, the prevalence of breast cancer in the general population, based on data from the New Jersey Department of Health and Senior Services, was significantly lower at 1.6%.

Two of the 28 patients with breast cancer had low TSH levels, but one had a free T4 within normal limits and the other had a total T4 within normal limits, said Dr. Sanghvi. Four of the 28 patients had serum thyroid peroxidase (TPO) antibodies, only one level of which was elevated, but this patient had normal TSH and free T4 levels, Dr. Sanghvi said.

The association between breast cancer and nontoxic goiter is unclear, she said. Possible mechanisms include the role of iodine, thyroid-stimulating hormone, and estrogen.

"Iodine has been theorized as being a causative factor, because it is utilized by both breast and thyroid tissues," and these are the only two organs in which iodine is stored. Dr. Sanghvi explained. However, epidemiologic studies are needed to explore the association between iodine and breast cancer, she said.

The results were limited by the retrospective nature of the study, and the lack of a standard medical history questionnaire. But they underscore the important of breast cancer screening in women with benign thyroid disease until larger, prospective studies provide additional information, Dr. Sanghvi said.

In the study population as a whole, the average age was 51 years, the average body mass index was 29.2 kg/m², the average TSH was 2.02 mIU/L, and the average free T4 was 1.67 ng/dL. Among the 28 patients with a family history of breast cancer, the average age was 57 years, the average BMI was 29 kg/m², the average TSH was 1.54 mIU/L, and the average free T4 was 1.14 ng/dL

One of the patients with breast cancer had ductal carcinoma in situ; the breast cancer types in the other 27 patients were not specified.

Dr. Sanghvi reported having no financial conflicts to disclose.