POSTMENOPAUSAL OSTEOPOROSIS

绝经后骨质疏松症

• 批准号: 6265512
• 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/6265512
• 关键词: bone density; bone fracture; clinical research; drug screening /evaluation; female; health care cost /financing; human subject; human therapy evaluation; inhibitor /antagonist; osteoporosis; physiologic bone resorption; postmenopause; quality of life; skeletal disorder chemotherapy; women's health

To determine whether risedronate is efficacious in reducing vertebral deformity incidnece (and rate) in osteoporosis postmenopausal women. To determine whether risedronate is efficacious in reducing all osteoporosis-related fracture incidence (and rate). To determine whether risedronate is associated with an increase in spine, proximal femur, and distal radius BMD during the study in osteoporotic postmenopausal women. (deletion of effect on health-related quality of life independent from its effect on fractures, and of effect on osteoporosis-related fractures on health-related quality of life per amendment III, August 95) To determine the influence of osteoporis-related fractures on health care services utilization and costs. To determine whether risedronate treatment reduces the general osteoporosis-related health care costs of osteoporotic postmenopausal women. To determine whether risedronate treatment is safe by monitoring the adverse events, hematological, hepatic, renal, and bone safety profiles; the latter will include cortical bone mass (midshaft radius and femoral neck), and histology/histomorphometry. Incidence refers to analysis at the patient level (expressed as the proportion of patients with at least one new fracture); rate refers to the anatomical site level (Count all fractures and express as number of fractures per 1,000 patient years) See Section XI for definition of new vertebral deformity.

确定利塞膦酸钠是否能有效降低绝经后骨质疏松妇女椎体畸形的发生率。 确定利塞膦酸钠是否能有效降低骨关节炎相关骨折的发生率。 在绝经后骨质疏松妇女的研究中，确定利塞膦酸钠是否与脊柱、股骨近端和桡骨远端BMD增加相关。（根据1995年8月修订案III，删除了对健康相关生活质量的影响（独立于其对骨折的影响），以及骨质疏松相关骨折对健康相关生活质量的影响）确定骨质疏松相关骨折对卫生保健服务利用和费用的影响。 确定利塞膦酸钠治疗是否能降低绝经后妇女乳腺癌相关的一般医疗费用。 通过监测不良事件、血液学、肝脏、肾脏和骨安全性特征来确定利塞膦酸盐治疗是否安全;后者将包括皮质骨量（中段桡骨和股骨颈）和组织学/组织形态学。 发生率是指患者水平的分析（表示为至少发生1例新发骨折的患者比例）;发生率是指解剖部位水平（计数所有骨折并表示为每1,000患者年的骨折数量），新发椎体畸形的定义见第XI节。