NCT04087096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 29, 2025

Completed
Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

September 10, 2019

Results QC Date

October 1, 2025

Last Update Submit

October 1, 2025

Conditions

Bariatric Surgery CandidateBone Loss

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Total Hip Bone Mineral Density

    Pre-operative baseline to post-operative month 19

Study Arms (2)

Denosumab

EXPERIMENTAL

Denosumab 60mg subcutaneous injection every 6 months

Drug: DenosumabDrug: Zoledronic Acid

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection every 6 months

Drug: PlaceboDrug: Zoledronic Acid

Interventions

DenosumabDRUG

Denosumab will be administered at postoperative months 1, 7, and 13

Also known as: Prolia
Denosumab
PlaceboDRUG

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

Placebo
Zoledronic AcidDRUG

Zoledronic Acid 5mg will be administered intravenously at postoperative month 19

Also known as: Reclast
DenosumabPlacebo

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • Tabira T. [Immunological abnormalities in multiple sclerosis]. No To Shinkei. 1983 Jun;35(6):535-41. No abstract available. Japanese.

    PMID: 6194805BACKGROUND

  • Ramirez-Lassepas M, Quinones MR. Heparin therapy for stroke: hemorrhagic complications and risk factors for intracerebral hemorrhage. Neurology. 1984 Jan;34(1):114-7. doi: 10.1212/wnl.34.1.114.

    PMID: 6537834BACKGROUND

  • Marina Fiol C. [Treatment of the hepatic repercussions of cholelithiasis]. Minerva Med. 1966 Jul 14;57(56):2550-2. No abstract available. Italian.

    PMID: 6002877BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

DenosumabZoledronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Elaine Yu
Organization
Massachusetts General Hospital
EWYU@mgh.harvard.edu
617-643-6353

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 12, 2019

Study Start

August 24, 2020

Primary Completion

August 6, 2024

Study Completion

August 6, 2024

Last Updated

October 29, 2025

Results First Posted

October 29, 2025

Record last verified: 2025-10

Locations

US(2)