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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study for Zoledronic Acid to Prevent High-Turnover Bone Loss After Bariatric Surgery

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Drug: Zoledronic Acid
* Dietary Supplement: Calcium citrate + vitamin D
* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men must be age ≥ 50 Women must be age ≥ 25 and postmenopausal Planning to receive RYGB or SG surgery 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Zoledronic Acid, Calcium+Vitamin D<br>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<br>* 5mg zoledronic acid<br>* Other names: National Drug Code (NDC) 25021-830-82;Dietary Supplement: Calcium citrate + vitamin D<br>* Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3<br>Dietary Supplement: Vitamin D3<br>* 1000IU Vitamin D3 gummy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | 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). | 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). | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roux-en-Y gastric bypass, sleeve gastrectomy