Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
研究概览
简要总结
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women age 21 years or older
- •Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening
排除标准
- •Taking bisphosphonates within past 6 months
- •More than 30 micrograms/day of estradiol or equivalent in past 3 months
- •History of alcoholism or drug abuse in past year
- •Pregnant women or nursing mothers
研究组 & 干预措施
A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
干预措施: Teriparatide (Drug)
A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
干预措施: Placebo (Drug)
B
Alendronate 10 mg/day oral plus injection placebo, 36 months
干预措施: Alendronate Sodium (Drug)
B
Alendronate 10 mg/day oral plus injection placebo, 36 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
时间窗: 18 month endpoint
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
次要结局
- Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset(18 month endpoint)
- Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined(3, 6, 12, 18, 24, 36 months)
- Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset(3, 6, 12, and 18 months)
- Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined(24 and 36 months and Endpoint at 36 months)
- Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined(18, 24, 36 months, and 18 and 36 month endpoints)
- Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined(18, 24, 36 months, and 18 and 36 month endpoints)
- Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined(12, 18, 24, and 36 months)
- Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined(12, 18, 24, and 36 months)
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen(1, 6, 18, and 36 months)
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen(1, 6, 18, and 36 months)
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase(1, 6, 18, and 36 months)
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments(1, 6, 18, and 36 months)
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin(1, 6, 18, and 36 months)
- Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures(36 months)