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Bone loss after bariatric surgery: could denosumab be the answer?

NCT ID NCT04087096

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

Bariatric surgery can lead to bone loss and increase fracture risk. This study tested whether denosumab, a drug used for osteoporosis, could prevent that bone loss. The trial included 36 postmenopausal women and men aged 50 and older who were planning weight-loss surgery. Participants received denosumab or a placebo at 1, 7, and 13 months after surgery, with a follow-up dose of zoledronic acid at 19 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Denosumab (Prolia)
What this could lead to
If it works, this could point toward a way to protect bones after bariatric surgery, reducing fracture risk.
What could go wrong
This is a small, early-phase trial with only 36 participants, so results may not apply to everyone. Bone loss prevention may not be fully achieved.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

36 people

The number who actually took part.

Started

Aug 2020

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bariatric surgery candidate Bone loss

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

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