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

NCT03424239 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2017P002081
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery Candidate

Keywords

Roux-en-Y gastric bypass, sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Total Hip Bone Mineral Density by DXA

  Baseline and 6 months

• Change in Trabecular Spine Bone Mineral Density by QCT

  Baseline and 6 months

• Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0

  6 months

• Change From Baseline of Femoral Neck Bone Density Measured by DXA

  Baseline and 6 months

• Change From Baseline of Spine Bone Density Measured by DXA

  Baseline and 6 months

Study Arms (1)

Drug: Zoledronic Acid, Calcium+Vitamin D

EXPERIMENTAL

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; Dietary Supplement: Calcium citrate + vitamin D; Dietary Supplement: Vitamin D3

Interventions

Zoledronic Acid DRUG

5mg zoledronic acid

Also known as: National Drug Code (NDC) 25021-830-82

Drug: Zoledronic Acid, Calcium+Vitamin D

Calcium citrate + vitamin D DIETARY_SUPPLEMENT

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

Drug: Zoledronic Acid, Calcium+Vitamin D

Vitamin D3 DIETARY_SUPPLEMENT

1000IU Vitamin D3 gummy

Drug: Zoledronic Acid, Calcium+Vitamin D

Eligibility Criteria

• Age: 25 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men must be age ≥ 50
• Women must be age ≥ 25 and postmenopausal
• Planning to receive RYGB or SG surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Zoledronic Acid; Calcium Citrate; Vitamin D; Cholecalciferol

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Calcium Compounds; Inorganic Chemicals; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Elaine Yu
• Organization: Massachusetts General Hospital

ewyu@mgh.harvard.edu

617-643-6353

Study Officials

• Elaine W Yu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

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

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 6, 2018
• Study Start: August 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)