Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

October 17, 2023 updated by: Elaine W. Yu, Massachusetts General Hospital
Bariatric surgery leads to bone loss and increases fracture risk. This study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Bariatric surgery is a highly effective weight loss treatment, but one of the unintended side effects of these procedures is high-turnover bone loss and metabolic bone disease. Denosumab is a monoclonal antibody to RANKL that acts as a potent inhibitor of bone resorption. The investigators are conducting a randomized placebo-controlled trial to evaluate the ability of denosumab to prevent bone loss after RYGB or SG surgery in older adults. At the conclusion of the study, all participants will be given zoledronic acid.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Postmenopausal women who are planning RYGB or SG surgery
  • Men aged ≥ 50 years who are planning RYGB or SG surgery

Exclusion criteria:

  • Prior bariatric surgery
  • Weight = 400 lbs (due to limitations of bone imaging equipment)
  • Renal disease
  • Hypercalcemia or hypocalcemia
  • Hypomagnesemia
  • Serum 25-OH vitamin D (25OHD) < 20 ng/mL
  • Hyperparathyroidism
  • Liver disease (AST or ALT > 2 x upper normal limit)
  • HCT < 32%
  • History of malignancy (except basal cell carcinoma) in the past 1 year
  • Significant cardiopulmonary disease
  • Major psychiatric disease
  • History of celiac disease or inflammatory bowel disease
  • Excessive alcohol or substance abuse
  • Paget's disease, primary hyperparathyroidism, or any other known congenital or acquired bone disease other than osteoporosis
  • Current hyperthyroidism or use of levothyroxine with TSH < 0.1 uIU/mL
  • Current use of loop diuretics
  • Current use or use in the past 12 months of oral bisphosphonates or DMAB
  • Current use or use within the past 3 months of SERMs or calcitonin
  • Current use or use within the past 3 months of estrogen
  • Use of testosterone therapy if dose has changed within the last 3 months, or if dose change or discontinuation is planned in the upcoming 18 months
  • Any current or previous use of teriparatide, strontium, or any parenteral bisphosphonate
  • Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
  • Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 18 months
  • DXA BMD T-score of < -3.0 at PA spine, total hip, or femoral neck
  • Current use of anti-VEGF drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Denosumab
Denosumab 60mg subcutaneous injection every 6 months
Drug: Denosumab
Denosumab will be administered at postoperative months 1, 7, and 13
Other Names:
  • Prolia
Drug: Zoledronic Acid
Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
Other Names:
  • Reclast
Placebo Comparator: Placebo
Placebo subcutaneous injection every 6 months
Drug: Zoledronic Acid
Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
Other Names:
  • Reclast
Drug: Placebo
Placebo will be administered at postoperative months 1, 7, and 13

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in total hip bone mineral density
Time Frame: Pre-operative baseline to post-operative month 19
Pre-operative baseline to post-operative month 19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

University of California, San Francisco
San Francisco VA Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20187525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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