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Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04087096
Collaborator
University of California, San Francisco (Other), San Francisco VA Health Care System (U.S. Fed)
36
Enrollment
2
Locations
2
Arms
35.2
Anticipated Duration (Months)
18
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
Actual Study Start Date :
Aug 24, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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: Placebo
    Placebo will be administered at postoperative months 1, 7, and 13

    Drug: Zoledronic Acid
    Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
    Other Names:
  • Reclast

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage change in total hip bone mineral density [Pre-operative baseline to post-operative month 19]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143
    2 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • University of California, San Francisco
    • San Francisco VA Health Care System

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Elaine W. Yu, Assistant Professor, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04087096
    Other Study ID Numbers:
    • 20187525
    First Posted:
    Sep 12, 2019
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bone Diseases, Metabolic
    Zoledronic Acid
    Denosumab

    Study Results

    No Results Posted as of Apr 5, 2022