NCT00365924已完成不适用
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
研究概览
简要总结
This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with osteoporosis
排除标准
- •Any therapies or products affecting bone turnover within 12 months of Screening.
- •Bisphosphonate treatment >1 month in total duration at any time in the past.
- •In addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to Screening.
研究组 & 干预措施
Forteo
Other
干预措施: Forteo (Drug)
结局指标
主要结局
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
时间窗: 12 months
次要结局
- Changes in BMD and bone biomarkers following 12 months of therapy with Forteo(12 months)
研究者
研究点 (1)
Loading locations...
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