OSTEOPOROSIS

骨质疏松症

• 批准号: 6265518
• 负责人: NORMAN L BELL
• 金额: $ 1.74万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265518
• 关键词: alendronate; bone density; bone metabolism; clinical research; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; male; osteoporosis; skeletal disorder chemotherapy

To assess the treatment effect of oral alendronate 10 mg/day versus placebo on the change in BMD of the spine when administered for up to 24 months in men with osteoporosis. To define the safety/tolerability profile of oral alendronate when administered in men with osteoporosis. To assess the treatment effects of alendronate 10 mg/day versus placebo on the change in hip and total body BMD when administered for 24 months in men with osteoporosis. To examine the effects of alendronate 10 mg/day on biochemical markers of bone turnover (urinary N-telopeptide crosslinks and serum bone-specific alkaline phosphatase) in men with osteoporosis. To examine the relationship between the changes in bone mass at the spine and baseline: (a) BMD, (b) biochemical markers of bone turnover (c) gonadal status (d) age (e) geographic location (U.S. vs non-U.S.) (f) renal function (g) height.

评估口服阿仑膦酸钠10 mg/天与安慰剂相比，在骨质疏松症男性中给药长达24个月时对脊柱BMD变化的治疗效果。 确定口服阿仑膦酸钠在骨质疏松症男性中的安全性/耐受性特征。 评估阿仑膦酸钠10 mg/天与安慰剂相比，在骨质疏松症男性中给药24个月后对髋部和全身BMD变化的治疗效果。 研究阿仑膦酸钠10 mg/天对骨质疏松症男性骨转换生化标志物（尿N-端肽交联和血清骨特异性碱性磷酸酶）的影响。 检查脊柱骨量变化与基线之间的关系：（a）BMD，（B）骨转换生化标志物（c）性腺状态（d）年龄（e）地理位置（美国vs非美国）(f)肾功能（g）身高。