A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 294
- 主要终点
- Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
研究概览
简要总结
The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.
详细描述
The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Is a male between 40 and 95 years of age
- •Has osteoporosis
- •Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
- •Is ambulatory
排除标准
- •Is currently on oral bisphosphonates or other treatment for osteoporosis
- •Had previous hip fragility fracture and is a candidate for standard of care therapy
- •Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
- •Has had more then one previous vertebral fracture
- •Has been diagnosed with metabolic bone disorder other than osteoporosis
- •Is Vitamin D deficient
- •Has a history of renal stones
- •Has active parathyroid disease
- •Has history of thyroid disease not well controlled by medication
- •Is diagnosed with secondary osteoporosis
- •Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg
- •Has a history of malignancy ≤5 years prior to signing informed consent
- •Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems
研究组 & 干预措施
Odanacatib 50 mg once weekly
Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
干预措施: Odanacatib (Drug)
Odanacatib 50 mg once weekly
Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
干预措施: Vitamin D3 (Dietary Supplement)
Odanacatib 50 mg once weekly
Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
干预措施: Calcium carbonate (Dietary Supplement)
Placebo once weekly
Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
干预措施: Placebo for Odanacatib (Drug)
Placebo once weekly
Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
干预措施: Vitamin D3 (Dietary Supplement)
Placebo once weekly
Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
干预措施: Calcium carbonate (Dietary Supplement)
结局指标
主要结局
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
时间窗: Baseline and Month 24
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
Number of Participants Who Discontinued Treatment Due to an AE
时间窗: Up to 24 months after first dose of study drug
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Number of Participants Who Experienced an Adverse Event (AE)
时间窗: Up to 24 months (plus 14 days) after first dose of study drug
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
次要结局
- Percentage Change From Baseline in Femoral Neck BMD at Month 24(Baseline and Month 24)
- Percentage Change From Baseline in Trochanter BMD at Month 24(Baseline and Month 24)
- Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24(Baseline and Month 24)
- Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24(Baseline and Month 24)
- Percentage Change From Baseline in Total Hip BMD at Month 24(Baseline and Month 24)
- Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24(Baseline and Month 24)
- Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24(Baseline and Month 24)