NCT00191893已完成3 期
Bone Effects of Subcutaneous Teriparatide Following Discontinuation of Alendronate Treatment in Postmenopausal Women With Osteoporosis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies.
研究概览
简要总结
The purpose of this study is to assess the effect of 24 months of treatment with once daily teriparatide injection (recombinant human PTH [1-34]) 20 micrograms on bone histomorphometry and architecture. Patients will include postmenopausal, osteoporotic women who have been treated long term (at least 36 months) with alendronate, as well as postmenopausal, osteoporotic women who have never been treated for osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Osteoporosis: Pretreated patients currently osteoporotic or osteopenic. Treatment-naive patients currently osteoporotic
- •Pretreated patients will have had at least 36 months of treatment with alendronate Na 10 mg/day or 70 mg/week. Treatment-naive patients will have no significant osteoporosis treatment in the prior 36 months, as assessed by the investigator
排除标准
- •History of bone metabolic diseases, Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption.
- •History of malignant neoplasms in the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease.
结局指标
主要结局
conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies.
次要结局
- BMD (DXA, Holoc Delphi A),Biochemical markers of bone metabolism,3-D bone morphology by high resolution quantitative Computed Tomography (QCT)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
不适用
Teriparatide (PTH) and Bone Strength in Postmenopausal WomenOsteoporosisNCT01155245University Health Network, Toronto60
已完成
4 期
Bone Marker Changes With Teriparatide/Postmenopausal OsteoporosisOsteoporosis, Post-MenopausalNCT00532545Eli Lilly and Company45
已完成
不适用
Effect of once-weekly teriparatide for bone metabolism in praimary osteoprosis patients.JPRN-UMIN000032090Kindai University Hospital Department of Orthopaedic surgery50
已完成
不适用
Effect of once-weekly teriparatide for bone metabolism in primary osteoprosis patients.OsteoprosisJPRN-UMIN000033118Kindai University Hospital, Department of Orthopaedic surgery30
进行中（未招募）
不适用
Effects of Teriparatide (PTH) on Bone in Men and Women With OsteoporosisOsteoporosisNCT01155232University Health Network, Toronto100