NCT01437111已完成3 期
A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatment of Osteoporosis in Postmenopausal Women and Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
研究概览
简要总结
This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D [25(OH)D].
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Man aged 50 or older, or a woman who is postmenopausal on day of signing informed consent or has been menopausal for at least one year
- •Meets bone mineral density (BMD) criteria
- •Agree to discontinue any osteoporosis drug treatment for duration of study
排除标准
- •Any contraindication to alendronate and vitamin D
- •Not ambulatory
- •Has received treatment with any anabolic steroid agent within the past 12 months, systemic glucocorticoids, for more than 2 weeks in the past 6 months, current use of immunosuppressants, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months, treated with parathyroid hormone (PTH) for more than 2 weeks within the past 3 months, current use of chemotherapy or heparin, use of growth hormone for more than 2 weeks within the past 6 months, use of active hormonal vitamin D analogs in the past 2 months, current use of vitamin A >10,000 IU daily, current use of, lithium, or anti-convulsants including barbiturates, hydantoins, and carbamazepine, current use of calcium supplement in amount excess of 1500 mg daily, and/or current use of Vitamin D supplement
- •History of malignancy <5 years, except adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer
- •One or more of the following concomitant conditions: Upper gastrointestinal (GI) disorders not adequately controlled; myocardial infarction, unstable angina, stroke and revascularization condition within 3 months; malabsorption syndrome; primary or secondary hyperparathyroidism not adequately treated; thyroid disease not adequately controlled; severe renal insufficiency; uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; uncontrolled hypertension; new onset diabetes (within 3 months), poorly controlled hyperglycemia, or hypoglycemia for any cause; evidence for metabolic bone disease other than osteoporosis; abnormal indices of calcium metabolism; and/or active renal stone disease
- •User of illicit recreational drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
- •Heavy consumer of alcohol or alcohol containing products.
研究组 & 干预措施
Fosamax Plus
Experimental
Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants
干预措施: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Drug)
结局指标
主要结局
Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
时间窗: Week 26
Serum samples to measure serum 25-hydroxyvitamin D \[25(OH)D\] will be collected at specific visits during the treatment phase of the study.
次要结局
- Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26(Baseline and Week 26)
研究者
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