Bariatric Surgery CandidatePhase 4NCT04087096
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
A Phase 4 study testing Denosumab and Zoledronic Acid in people with Bariatric Surgery Candidate and Bone Loss, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Bone Loss
- What is being tested?
- Denosumab and Zoledronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2020to 6 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women who are planning RYGB or SG surgery
- Men aged ≥ 50 years who are planning RYGB or SG surgery
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate, Bone Loss
- Being tested
- Denosumab, Placebo, Zoledronic Acid
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Prolia
Denosumab will be administered at postoperative months 1, 7, and 13
PlaceboDrug
Placebo will be administered at postoperative months 1, 7, and 13
Zoledronic AcidDrug
Also called Reclast
Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | Denosumab 60mg subcutaneous injection every 6 months Receives: Drug: Denosumab; Drug: Zoledronic Acid |
| Placebo | Placebo comparator | Placebo subcutaneous injection every 6 months Receives: Drug: Placebo; Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Total Hip Bone Mineral Density
Measured: Pre-operative baseline to post-operative month 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start24 Aug 2020
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, San Francisco VA Health Care System
- Responsible party
- Principal investigator, Elaine W. Yu, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087096
- Sponsor's protocol ID
- 20187525
- Other IDs
- 20187525
- Status last verified
- Oct 2025
- First submitted
- 10 Sep 2019
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lindeman KG, Greenblatt LB, Rourke C, Bouxsein ML, Finkelstein JS, Yu EW. Longitudinal 5-Year Evaluation of Bone Density and Microarchitecture After Roux-en-Y Gastric Bypass Surgery. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4104-4112. doi: 10.1210/jc.2018-01496.
PubMed 30219833Yu EW, Kim SC, Sturgeon DJ, Lindeman KG, Weissman JS. Fracture Risk After Roux-en-Y Gastric Bypass vs Adjustable Gastric Banding Among Medicare Beneficiaries. JAMA Surg. 2019 Aug 1;154(8):746-753. doi: 10.1001/jamasurg.2019.1157.
PubMed 31090893Schafer AL, Kazakia GJ, Vittinghoff E, Stewart L, Rogers SJ, Kim TY, Carter JT, Posselt AM, Pasco C, Shoback DM, Black DM. Effects of Gastric Bypass Surgery on Bone Mass and Microarchitecture Occur Early and Particularly Impact Postmenopausal Women. J Bone Miner Res. 2018 Jun;33(6):975-986. doi: 10.1002/jbmr.3371. Epub 2018 Feb 5.
PubMed 29281126
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04087096
- Acronym / sponsor ID
- 20187525
- Conditions
- Bariatric Surgery Candidate, Bone Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of California, San Francisco, San Francisco VA Health Care System
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: Denosumab, Drug: Zoledronic AcidDenosumab 60mg subcutaneous injection every 6 months |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Zoledronic AcidPlacebo subcutaneous injection every 6 months |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women who are planning RYGB or SG surgery
- Men aged ≥ 50 years who are planning RYGB or SG surgery
Key exclusion criteria (26 listed)
- Prior bariatric surgery
- Weight = 400 lbs (due to limitations of bone imaging equipment)
- Renal disease
- Hypercalcemia or hypocalcemia
- Hypomagnesemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabAlso: ProliaDenosumab will be administered at postoperative months 1, 7, and 13 | Drug | Denosumab |
| PlaceboPlacebo will be administered at postoperative months 1, 7, and 13 | Drug | Placebo |
| Zoledronic AcidAlso: ReclastZoledronic Acid 5mg will be administered intravenously at postoperative month 19 | Drug | Denosumab, Placebo |
Primary outcome
Percentage Change in Total Hip Bone Mineral Density
Time frame: Pre-operative baseline to post-operative month 19
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30219833Lindeman KG, Greenblatt LB, Rourke C, Bouxsein ML, Finkelstein JS, Yu EW. Longitudinal 5-Year Evaluation of Bone Density and Microarchitecture After Roux-en-Y Gastric Bypass Surgery. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4104-4112. doi: 10.1210/jc.2018-01496.
- Background: PubMed 31090893Yu EW, Kim SC, Sturgeon DJ, Lindeman KG, Weissman JS. Fracture Risk After Roux-en-Y Gastric Bypass vs Adjustable Gastric Banding Among Medicare Beneficiaries. JAMA Surg. 2019 Aug 1;154(8):746-753. doi: 10.1001/jamasurg.2019.1157.
- Background: PubMed 29281126Schafer AL, Kazakia GJ, Vittinghoff E, Stewart L, Rogers SJ, Kim TY, Carter JT, Posselt AM, Pasco C, Shoback DM, Black DM. Effects of Gastric Bypass Surgery on Bone Mass and Microarchitecture Occur Early and Particularly Impact Postmenopausal Women. J Bone Miner Res. 2018 Jun;33(6):975-986. doi: 10.1002/jbmr.3371. Epub 2018 Feb 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab and Zoledronic Acid in people with Bariatric Surgery Candidate and Bone Loss, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Total Hip Bone Mineral Density (time frame: Pre-operative baseline to post-operative month 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087096, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.