NCT00004406已完成不适用
Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
OBJECTIVES:
I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 29 Years 至 67 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Impact of Parathyroid Hormone (PTH) on Osseous CavityBone LossPeriodontitisNCT00277706University of Michigan40
已完成
2 期
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal WomenPostmenopausal OsteoporosisOsteoporosisNCT00086619Massachusetts General Hospital80
撤回
1 期
One Week Comparison Study of PTH and PTHrP InfusionsHyperparathyroidismHypercalcemia of MalignancyBone Diseases, EndocrineOsteoporosisNCT01333267University of Pittsburgh
尚未招募
不适用
The Bone-parathyroid Crosstalk in Primary HyperparathyroidismHyperparathyroidism, PrimaryParathyroid NeoplasmsOsteoporosisNCT05556499I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio100
已完成
2 期
Bone Properties in Hypoparathyroidism: Effects of PTHHypoparathyroidismNCT00473265John P. Bilezikian68