Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Change in Lumbar Spine Areal Bone Mineral Density (BMD)
研究概览
简要总结
This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.
详细描述
The study has 3 periods: a screening phase, a double-blind, double-dummy treatment phase from the time of randomization to the 26 weeks visit, and an open-label treatment phase of approximately 12 month duration, where participants will continue treatment with the same study drug that they were randomized to.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region
- •Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men
排除标准
- •Clinically significant abnormal laboratory values
- •History of unresolved skeletal diseases that affect bone metabolism
- •Polytrauma participants and participants with fractures at more than one site
研究组 & 干预措施
Teriparatide
20 micrograms (mcg) a day by subcutaneous injection throughout study.
Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only.
干预措施: Teriparatide (Drug)
Teriparatide
20 micrograms (mcg) a day by subcutaneous injection throughout study.
Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only.
干预措施: Placebo (Drug)
Teriparatide
20 micrograms (mcg) a day by subcutaneous injection throughout study.
Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only.
干预措施: Calcium (Dietary Supplement)
Teriparatide
20 micrograms (mcg) a day by subcutaneous injection throughout study.
Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only.
干预措施: Vitamin D (Dietary Supplement)
Risedronate
35 milligrams (mg) risedronate sodium orally once weekly throughout study.
Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only.
干预措施: Risedronate (Drug)
Risedronate
35 milligrams (mg) risedronate sodium orally once weekly throughout study.
Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only.
干预措施: Placebo (Drug)
Risedronate
35 milligrams (mg) risedronate sodium orally once weekly throughout study.
Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only.
干预措施: Calcium (Dietary Supplement)
Risedronate
35 milligrams (mg) risedronate sodium orally once weekly throughout study.
Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Change in Lumbar Spine Areal Bone Mineral Density (BMD)
时间窗: Baseline, Week 78
Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
次要结局
- Visual Analog Scale (VAS)(6, 12, 18, and 26 Weeks)
- Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire(Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26)
- Change in Lumbar Spine Areal Bone Mineral Density(Baseline, Week 26; Baseline, Week 52)
- Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb(Baseline, Week 26; Baseline, Week 52; Baseline, Week 78)
- Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale(Baseline)
- Timed "Up and Go" Test(6, 12, 18, and 26 Weeks)