A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK-0822 in the Treatment of Involutional Osteoporosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 287
- 主要终点
- Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)
研究概览
简要总结
The purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis participants. The study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants.
The study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium carbonate. The primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. The primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85
- •Participant who has low bone mineral density
- •Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumber spine and hip
- •Participant is ambulatory (can walk)
排除标准
- •Participant has secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia
- •Participant has received osteoporosis medications or other medications that affect bone
- •Participant is already participating in another drug study
研究组 & 干预措施
Placebo
After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Vitamin D3 (Dietary Supplement)
Placebo
After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Calcium carbonate (Dietary Supplement)
Placebo
After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Placebo (Drug)
Odanacatib 10 mg
After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Odanacatib (Drug)
Odanacatib 10 mg
After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Vitamin D3 (Dietary Supplement)
Odanacatib 10 mg
After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Calcium carbonate (Dietary Supplement)
Odanacatib 25 mg
After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Odanacatib (Drug)
Odanacatib 25 mg
After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Vitamin D3 (Dietary Supplement)
Odanacatib 25 mg
After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Calcium carbonate (Dietary Supplement)
Odanacatib 50 mg
After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Odanacatib (Drug)
Odanacatib 50 mg
After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Vitamin D3 (Dietary Supplement)
Odanacatib 50 mg
After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
干预措施: Calcium carbonate (Dietary Supplement)
结局指标
主要结局
Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)
时间窗: Baseline (Observation visit to Wk 0 treatment visit), Week 52
BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = (\[BMD at Week 52 visit\] - \[baseline BMD\] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.
Number of Participants That Experienced an Adverse Event (AE)
时间窗: From first dose up to Post-Study (up to 54 weeks)
An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
Number of Participants That Discontinued Study Drug Due to an AE
时间窗: From first dose up to end of treatment (up to 52 weeks)
An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm. Participants may have discontinued study drug but continued on the trial.
次要结局
- Percent Change From Baseline to Week 52 in Total Hip BMD(Baseline (Observation visit to Wk 0 treatment visit), Week 52)
- Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre)(Baseline (Wk 0), Week 52)
- Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio(Baseline (Wk 0), Week 52)
- Percent Change From Baseline to Week 52 in Trochanter BMD(Baseline (Observation visit to Wk 0 treatment visit), Week 52)
- Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level(Baseline (Wk 0), Week 52)
- Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level(Baseline (Wk 0), Week 52)
- Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level(Baseline (Wk 0), Week 52)
- Percent Change From Baseline to Week 52 in Femoral Neck BMD(Baseline (Observation visit to Wk 0 treatment visit), Week 52)