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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
6
5mg zoledronic acid
Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3
1000IU Vitamin D3 gummy
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in Serum CTX
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.
Time frame: Baseline and 6 months
Change in Total Hip Bone Mineral Density by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
Change in Trabecular Spine Bone Mineral Density by QCT
Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT).
Time frame: Baseline and 6 months
Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0
Hypocalcemia, if detected, will be graded according to common terminology for adverse event criteria (CTCAE v.4). Adverse events considered related or possibly related are counted.
Time frame: 6 months
Change From Baseline of Femoral Neck Bone Density Measured by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
Change From Baseline of Spine Bone Density Measured by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
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