Effect of Bisphosphonate Use on Surgical Weight Loss Associated Bone Loss in Older Adults With Morbid Obesity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Enrolled Participants That Completed All 24 Week Procedures
研究概览
简要总结
This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT) examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical weight loss associated loss of bone mass and quality.
详细描述
This pilot study is a RCT, involving 24 participants randomized to Risedronate or placebo capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be approached during their pre-surgical evaluation for possible participation in the study. Eligible participants will be referred onto the study coordinator to read/sign an IRB-approved informed consent prior to enrollment.
Two in-person baseline assessment visits [baseline visit 1 (BV1), baseline visit 2 (BV2)] occurring 1-6 weeks prior to surgery, and two in-person follow up assessment visits [follow up visit 1 (FV1) and follow up visit 2 (FV2)] occurring ±2 weeks from their 23-week post-surgery date will be conducted, as well as monthly medication compliance reminders and adverse event reporting via phone. Optional additional exploratory assessments include CT-derive bone health and blood-based biomarkers, as well as 12-month DXA, CT, and blood assessments. The Wake Forest WMC, under the direction of Drs. Ard and Fernandez, will serve as a source of recruitment for potential study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Both participant and research associate charged with administering medication or placebo capsules will be blinded.
入排标准
- 年龄范围
- 40 Years 至 79 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Risedronate
Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.
干预措施: Risedronate Sodium 150 MG (Drug)
Placebo
Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Enrolled Participants That Completed All 24 Week Procedures
时间窗: 24 weeks
次要结局
- Fat Pounds(24 weeks)
- Lean Pounds(24 weeks)
- Total Change in Femoral Neck Hip Density(Baseline and 24 weeks)
- Total Change in Lumbar Spine Density(Baseline and 24 weeks)
- Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density(24 weeks)
- Trabecular Bone Score (TBS)(24 weeks)
