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Monoclonal Antibodies

Denosumab for Bone Loss After Bariatric Surgery

Phase 4

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Postmenopausal women who are planning RYGB or SG surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operative baseline to post-operative month 19

Awards & highlights

Study Summary

This trial finds that denosumab can prevent bone loss after RYGB and SG surgery.

Who is the study for?

This trial is for men over 50 and postmenopausal women planning to undergo Roux-en-Y Gastric Bypass or sleeve gastrectomy surgery. Participants must not be excessively overweight, have certain thyroid, bone, heart, kidney or liver conditions, a recent history of cancer (except skin), major psychiatric disease, substance abuse issues or be on specific medications.Check my eligibility

What is being tested?

The study is testing if Denosumab can prevent rapid bone loss after bariatric surgery compared to a placebo and Zoledronic Acid. It's designed to see which treatment is better at maintaining healthy bones in patients who've had weight-loss surgery.See study design

What are the potential side effects?

Denosumab may cause low calcium levels in the blood, infections, skin rashes or itching. Zoledronic Acid could lead to flu-like symptoms, joint pain and potential jawbone problems. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man aged 50 or older planning to have weight loss surgery.

Select...

I am a postmenopausal woman planning to undergo weight loss surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operative baseline to post-operative month 19

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operative baseline to post-operative month 19

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative baseline to post-operative month 19 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage change in total hip bone mineral density

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256

44%

joint pain

22%

nausea

22%

propagation of fracture at biopsy site

11%

dizziness

11%

rhinorrhea

100%

80%

60%

40%

20%

Study treatment Arm

Denosumab Only

Teriparatide Only

Denosumab and Teriparatide

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DenosumabExperimental Treatment2 Interventions

Denosumab 60mg subcutaneous injection every 6 months

Group II: PlaceboPlacebo Group2 Interventions

Placebo subcutaneous injection every 6 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Denosumab

2017

Completed Phase 4

~12500

Zoledronic Acid

2008

Completed Phase 4

~13830

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER

2,500 Previous Clinical Trials

15,236,435 Total Patients Enrolled

11 Trials studying Osteoporosis

7,406 Patients Enrolled for Osteoporosis

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,319 Total Patients Enrolled

20 Trials studying Osteoporosis

1,325 Patients Enrolled for Osteoporosis

San Francisco VA Health Care SystemFED

9 Previous Clinical Trials

864,925 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this clinical trial ongoing?

"According to the clinicaltrials.gov website, this medical trial is actively recruiting participants. It was initially made public on August 24th 2020 and has since been revised on April 4th 2022."

Answered by AI

In what conditions has Denosumab demonstrated efficacy?

"Denosumab is typically administered to skeletally mature patients, but it can also provide relief from various medical conditions such as glucocorticoid-induced osteoporosis, tumoral calcinosis, and androgen deprivation therapy."

Answered by AI

Could you please elucidate the safety profile of Denosumab?

"Based on its Phase 4 status, denosumab is rated a 3 for safety as it has already been approved."

Answered by AI

What prior experience has been documented with administering Denosumab?

"Denosumab was initially investigated in 2005 at Rosemere Cancer Centre, located within Royal Preston Hospital. Since the commencement of this research program, 18546 trials have been completed and 76 are presently ongoing - many of these out of San Francisco, California."

Answered by AI

How many participants are currently participating in this investigation?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this clinical trial is still open for recruitment. The study was initially shared to the public on August 24th 2020 and has seen a recent update as of April 4th 2022. 36 participants are sought at two different medical centres."

Answered by AI

Recent research and studies

The Journal of Clinical Endocrinology & MetabolismJournal

Longitudinal 5-year Evaluation of Bone Density and Microarchitecture After Roux-en-y Gastric Bypass Surgery

Lindeman, Katherine G, Logan B Greenblatt, Caroline Rourke, Mary L Bouxsein, Joel S Finkelstein, and Elaine W Yu. 2018. “Longitudinal 5-year Evaluation of Bone Density and Microarchitecture After Roux-en-y Gastric Bypass Surgery”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2018-01496.

Journal of Bone and Mineral ResearchJournal

Effects of Gastric Bypass Surgery on Bone Mass and Microarchitecture Occur Early and Particularly Impact Postmenopausal Women

Schafer, Anne L, Galateia J Kazakia, Eric Vittinghoff, Lygia Stewart, Stanley J Rogers, Tiffany Y Kim, Jonathan T Carter, et al.. 2018. “Effects of Gastric Bypass Surgery on Bone Mass and Microarchitecture Occur Early and Particularly Impact Postmenopausal Women”. Journal of Bone and Mineral Research. Wiley. doi:10.1002/jbmr.3371.

JAMA SurgeryJournal

Fracture Risk After Roux-en-y Gastric Bypass Vs Adjustable Gastric Banding Among Medicare Beneficiaries

Yu, Elaine W., Seoyoung C. Kim, Daniel J. Sturgeon, Katherine G. Lindeman, and Joel S. Weissman. 2019. “Fracture Risk After Roux-en-y Gastric Bypass Vs Adjustable Gastric Banding Among Medicare Beneficiaries”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2019.1157.

clinicaltrials.govStudy