Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
2009年2月13日 更新者：Eli Lilly and Company
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures.
Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma.
When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis."
This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
研究概览
研究类型
介入性
注册 (实际的)
428
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Aarhus、丹麦
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
-
-
-
Graz、奥地利
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Vienna、奥地利
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
-
-
-
Oslo、挪威
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
-
-
-
Brussels、比利时
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Gent、比利时
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Leuven、比利时
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
-
-
-
Carolina、波多黎各
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Ponce、波多黎各
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
-
-
California
-
Loma Linda、California、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Palo Alto、California、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
Colorado
-
Aurora、Colorado、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
North Dakota
-
Fargo、North Dakota、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Jamestown、North Dakota、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Men or women age 21 years or older
- Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening
Exclusion Criteria:
- Taking bisphosphonates within past 6 months
- More than 30 micrograms/day of estradiol or equivalent in past 3 months
- History of alcoholism or drug abuse in past year
- Pregnant women or nursing mothers
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
20 micrograms/day, injection, 36 months
其他名称：
Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
|
|
有源比较器：B
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
10 mg/day, oral, 36 months
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
大体时间：18 month endpoint
|
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
|
18 month endpoint
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
大体时间：18 month endpoint
|
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
|
18 month endpoint
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
大体时间：3, 6, 12, 18, 24, 36 months
|
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
|
3, 6, 12, 18, 24, 36 months
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
大体时间：3, 6, 12, and 18 months
|
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
|
3, 6, 12, and 18 months
|
|
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
大体时间：24 and 36 months and Endpoint at 36 months
|
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
|
24 and 36 months and Endpoint at 36 months
|
|
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
大体时间：18, 24, 36 months, and 18 and 36 month endpoints
|
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
|
18, 24, 36 months, and 18 and 36 month endpoints
|
|
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
大体时间：18, 24, 36 months, and 18 and 36 month endpoints
|
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
|
18, 24, 36 months, and 18 and 36 month endpoints
|
|
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
大体时间：12, 18, 24, and 36 months
|
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
|
12, 18, 24, and 36 months
|
|
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
大体时间：12, 18, 24, and 36 months
|
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
|
12, 18, 24, and 36 months
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
大体时间：1, 6, 18, and 36 months
|
1, 6, 18, and 36 months
|
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
大体时间：1, 6, 18, and 36 months
|
1, 6, 18, and 36 months
|
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
大体时间：1, 6, 18, and 36 months
|
1, 6, 18, and 36 months
|
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
大体时间：1, 6, 18, and 36 months
|
1, 6, 18, and 36 months
|
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
大体时间：1, 6, 18, and 36 months
|
1, 6, 18, and 36 months
|
|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
大体时间：36 months
|
Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.
|
36 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Saag KG, Agnusdei D, Hans D, Kohlmeier LA, Krohn KD, Leib ES, MacLaughlin EJ, Alam J, Simonelli C, Taylor KA, Marcus R. Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide. Arthritis Rheumatol. 2016 Sep;68(9):2122-8. doi: 10.1002/art.39726.
- Devogelaer JP, Adler RA, Recknor C, See K, Warner MR, Wong M, Krohn K. Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis. J Rheumatol. 2010 Jan;37(1):141-8. doi: 10.3899/jrheum.090411. Epub 2009 Nov 16.
- Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. doi: 10.1056/NEJMoa071408.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年11月1日
初级完成 (实际的)
2006年7月1日
研究完成 (实际的)
2008年1月1日
研究注册日期
首次提交
2003年1月13日
首先提交符合 QC 标准的
2003年1月13日
首次发布 (估计)
2003年1月14日
研究记录更新
最后更新发布 (估计)
2009年3月12日
上次提交的符合 QC 标准的更新
2009年2月13日
最后验证
2009年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.