Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery

Phase 4

Completed

Interventions: Drug: Zoledronic Acid
Dietary Supplement: Calcium citrate + vitamin D
Dietary Supplement: Vitamin D3

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Drug: Zoledronic Acid, Calcium+Vitamin D	Calcium citrate + 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.
Drug: Zoledronic Acid, Calcium+Vitamin D	Vitamin D3	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.
Drug: Zoledronic Acid, Calcium+Vitamin D	Zoledronic Acid	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.

Primary Outcome Measures

Name	Time	Method
Change in Serum CTX	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.

Secondary Outcome Measures

Name	Time	Method
Change in Total Hip Bone Mineral Density by DXA	Baseline and 6 months	Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0	6 months	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.
Change From Baseline of Spine Bone Density Measured by DXA	Baseline and 6 months	Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Change in Trabecular Spine Bone Mineral Density by QCT	Baseline and 6 months	Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT).
Change From Baseline of Femoral Neck Bone Density Measured by DXA	Baseline and 6 months	Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).