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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Bariatric Surgery Candidate

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03424239

2017P002081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 25 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Drug: Zoledronic Acid, Calcium+Vitamin D

Experimental group

Description:

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.

Treatment:

Drug: Zoledronic Acid

Dietary Supplement: Calcium citrate + vitamin D

Dietary Supplement: Vitamin D3