drugset / Trial / NCT04087096
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
Phase 4
Completed
36 enrolled
Massachusetts General Hospital
San Francisco VA Health Care System · collabUniversity of California, San Francisco · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2020-08-24
- Primary completion
- 2024-08-06
- Completion
- 2024-08-06
Publications
- Background 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.
- Background Yu 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 Schafer 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Background | Zoledronic acid | Other / unclassified | 5 mg | Intravenous |