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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中文摘要
翻译
目的:探讨利塞膦酸盐是否能有效降低绝经后骨质疏松症患者椎体畸形的发生率(及发生率)。目的:确定利塞膦酸盐在降低所有骨质疏松相关骨折发生率(和发生率)方面是否有效。目的:确定在绝经后骨质疏松妇女的研究中,利塞膦酸盐是否与脊柱、股骨近端和桡骨远端骨密度增加有关。(删除对健康相关生活质量的影响,独立于其对骨折的影响,以及删除对骨质疏松相关骨折的影响对健康相关生活质量的影响,修正案三,95年8月),以确定骨质疏松相关骨折对医疗服务利用和成本的影响。目的:确定利塞膦酸盐治疗是否降低了绝经后骨质疏松妇女与骨质疏松相关的一般医疗费用。通过监测不良事件、血液学、肝脏、肾脏和骨的安全性情况来确定利塞膦酸盐治疗是否安全;后者将包括皮质骨质量(骨干中段和股骨颈),以及组织学/组织形态计量学。发病率指的是患者层面的分析(以至少有一处新骨折的患者的比例表示);比率指的是解剖部位层面(计算所有骨折,并以每1000个病人年的骨折数表示),新椎体畸形的定义见第十一节。
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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