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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424239
• Other study ID #: 2017P002081
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Drug:
• Zoledronic Acid
5mg zoledronic acid

Dietary Supplement:
• Calcium citrate + vitamin D
Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3
• Vitamin D3
1000IU Vitamin D3 gummy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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