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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-01-01

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.

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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.

Conditions

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Bariatric Surgery Candidate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Zoledronic Acid

Intervention Type DRUG

5mg zoledronic acid

Calcium citrate + vitamin D

Intervention Type DIETARY_SUPPLEMENT

Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

1000IU Vitamin D3 gummy

Interventions

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Zoledronic Acid

5mg zoledronic acid

Intervention Type DRUG

Calcium citrate + vitamin D

Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

1000IU Vitamin D3 gummy

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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National Drug Code (NDC) 25021-830-82

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No