Pilot Study for Zoledronic Acid to Prevent High-Turnover Bone Loss After Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Serum CTX
研究概览
简要总结
This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.
详细描述
The investigators are evaluating the ability of a single dose of zoledronic acid to improve bone outcomes after RYGB or SG surgery. The investigators have previously shown that RYGB and SG have negative effects on bone density, bone microarchitecture, and that bariatric procedures potentially increase the risk of fractures. The purpose of this study is to evaluate the safety and efficacy of zoledronic acid to prevent the high-turnover bone loss that occurs in adults who have chosen to undergo RYGB or SG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men must be age ≥ 50
- •Women must be age ≥ 25 and postmenopausal
- •Planning to receive RYGB or SG surgery
排除标准
- •Age < 25
- •Prior bariatric surgery
- •Weight ≥ 400 lbs
- •Liver or renal disease
- •Hypercalcemia, hypocalcemia, or hypomagnesemia
- •Serum 25-hydroxyvitamin D < 20 ng/mL
- •History of bone-modifying disorders
- •Use of bone-active medications
- •Known sensitivity to bisphosphonates
- •Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 6 months
研究组 & 干预措施
Drug: Zoledronic Acid, Calcium+Vitamin D
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
干预措施: Zoledronic Acid (Drug)
Drug: Zoledronic Acid, Calcium+Vitamin D
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
干预措施: Calcium citrate + vitamin D (Dietary Supplement)
Drug: Zoledronic Acid, Calcium+Vitamin D
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change in Serum CTX
时间窗: Baseline and 6 months
The primary aim of this study is to determine the postoperative changes in serum markers of bone turnover after a preoperative infusion of zoledronic acid. Serum C-terminal telopeptide of type 1 collagen (CTX) is marker of bone resorption.
次要结局
- Change in Total Hip Bone Mineral Density by DXA(Baseline and 6 months)
- Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0(6 months)
- Change From Baseline of Spine Bone Density Measured by DXA(Baseline and 6 months)
- Change in Trabecular Spine Bone Mineral Density by QCT(Baseline and 6 months)
- Change From Baseline of Femoral Neck Bone Density Measured by DXA(Baseline and 6 months)
研究者
Elaine W. Yu
Assistant Professor of Medicine
Massachusetts General Hospital