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

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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Drug: Zoledronic Acid; Dietary supplement: Calcium citrate + vitamin D; Dietary supplement: Vitamin D3

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Zoledronic Acid; 5mg zoledronic acid; Other Names: National Drug Code (NDC) 25021-830-82; Dietary supplement: Calcium citrate + vitamin D; Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3; Dietary supplement: Vitamin D3; 1000IU Vitamin D3 gummy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Elaine W Yu, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Roux-en-Y gastric bypass, sleeve gastrectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Zoledronic Acid; Ergocalciferols
• Other Study ID Numbers: 2017P002081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No