NCT00926380已完成2 期
The Denosumab And Teriparatide Administration Study (DATA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change in Spine Bone Density From Baseline to 2 Years
研究概览
简要总结
The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must satisfy A and B and C and D below:
- •(A) Women aged > 55
- •(B) Postmenopausal
- •(C) Osteoporotic with high risk of fracture
排除标准
- •Confirmed serum alkaline phosphatase above upper normal limit with no explanation
- •Liver disease (AST or ALT > 2 x upper normal limit).
- •Renal disease (serum creatinine > 2.0 mg/dl).
- •Hypercalcemia (Ca >10.5 mg/dL)
- •Elevated blood PTH (intact PTH > 65 pg/ml)
- •Serum 25-OH vitamin D < 20 ng/ml
- •HCT < 32%.
- •History of malignancy (except basal cell carcinoma) or radiation therapy.
- •Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures.
- •Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- •Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- •Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease)
- •Current use or use in the past 6 months of oral bisphosphonate
- •Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.
- •Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months.
- •Any current or previous use of strontium or any parenteral bisphosphonate.
- •Known sensitivity to mammalian cell-derived drug products.
- •Known sensitivity to teriparatide or any of its excipients.
研究组 & 干预措施
denosumab and teriparatide (Forteo®)
Experimental
干预措施: teriparatide (Drug)
denosumab ONLY
Experimental
干预措施: denosumab (Drug)
teriparatide (Forteo®) ONLY
Experimental
干预措施: teriparatide (Drug)
denosumab and teriparatide (Forteo®)
Experimental
干预措施: denosumab (Drug)
结局指标
主要结局
Change in Spine Bone Density From Baseline to 2 Years
时间窗: Baseline and 2 years
次要结局
未报告次要终点
研究者
Benjamin Leder, MD
Principal Investigator, MD
Massachusetts General Hospital
研究点 (1)
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