A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK -0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of Osteoporosis in Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 主要终点
- Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26
研究概览
简要总结
A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for 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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •65 years or older
- •Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score <= -2.5 at spine or hip) or prior fragility fracture BMD T-score <=-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites
- •Postmenopausal
- •Low levels of vitamin D as measured 25-hydroxyvitamin D
- •Has fallen at least once within the past 12 months
排除标准
- •Unable to stand or sit upright for at least 30 minutes
- •Has a bone disorder other than osteoporosis
- •Contraindication to the use of FOSAVANCE
研究组 & 干预措施
FOSAVANCE 5600
alendronate sodium (+) cholecalciferol
干预措施: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol) (Drug)
FOSAVANCE 5600
alendronate sodium (+) cholecalciferol
干预措施: Calcium Supplement 500 mg (Dietary Supplement)
Referred-Care Model
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
干预措施: Referred-Care Model (Other)
结局指标
主要结局
Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26
时间窗: Week 26
Percentage of participants with serum levels of 25-hydroxyvitamin D below 20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls.
次要结局
- Falls Per Participant(Up to Week 52)
- Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio(Baseline and Week 52)
- Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio(Baseline and Week 26)
- Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase(Baseline and Week 26)
- Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density(Baseline and Week 52)
- Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52(Week 52)
- Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase(Baseline and Week 52)