课题基金 / 基金详情

POSTMENOPAUSAL OSTEOPOROSIS

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
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30

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项目成果

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中文摘要
翻译
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发生率。确定利塞膦酸钠是否有效降低所有骨质疏松相关骨折的发生率(和发生率)。在绝经后骨质疏松妇女研究中,确定利塞膦酸钠是否与脊柱、股骨近端和桡骨远端骨密度增加有关。(删除与骨折无关的对健康相关生活质量的影响,删除与骨质疏松相关骨折对健康相关生活质量的影响,参见1995年8月修订三)确定骨质疏松相关骨折对医疗保健服务利用和成本的影响。确定利塞膦酸钠治疗是否能降低绝经后骨质疏松妇女骨质疏松相关的医疗费用。通过监测不良事件、血液学、肝脏、肾脏和骨骼安全概况来确定利塞膦酸钠治疗是否安全;后者将包括皮质骨量(中轴半径和股骨颈)和组织学/组织形态计量学。发生率是指在患者水平上的分析(以至少有一次新骨折的患者比例表示);rate为解剖部位水平(计算所有骨折数,以每1000例患者年骨折数表示)新椎体畸形的定义见第11节。
英文摘要
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.
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TESTOSTERONE DEFICIENCY & BONE LOSS
POSTMENOPAUSAL OSTEOPOROSIS
POSTMENOPAUSAL OSTEOPOROSIS
POSTMENOPAUSAL OSTEOPOROSIS
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