Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
OBJECTIVES:
I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
研究概览
详细说明
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.
Patients are followed regularly for unacceptable toxicities.
Completion date provided represents the completion date of the grant per OOPD records
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10032
- Columbia University College of Physicians and Surgeons
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)
No family history of male osteoporosis
No other metabolic bone disease
--Prior/Concurrent Therapy--
Endocrine therapy:
- No concurrent glucocorticoid therapy
- No prior steroid use
Surgery: No prior gastrointestinal tract surgery
Other: No prior or concurrent anticonvulsant therapy
--Patient Characteristics--
Hematopoietic: Normal CBC
Hepatic: Normal liver function
Renal: Normal renal function
Other:
- Normal thyroid function
- Normal adrenal function
- Normal gonadal status
- No myeloma or other malignancy
- No alcoholism, hypercortisolism or diabetes mellitus
- No gastrointestinal tract disease or disorder associated with malabsorption
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 屏蔽:双倍的
合作者和调查者
调查人员
- 学习椅:John Paul Bilezikian、Columbia University
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
human parathyroid hormone的临床试验
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Arash Asher, MDVoxxLife招聘中
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Imperial College LondonCambridge University Hospitals NHS Foundation Trust; University of Edinburgh; University of Manchester 和其他合作者终止
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University of ConnecticutUnited States Department of Defense; AMP Human; Park City, UT完全的
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University of ConnecticutUnited States Department of Defense; AMP Human; Park City, UT完全的