Phase 4
N=36
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
Bariatric Surgery Candidate · Bone Loss
Bottom Line
View on ClinicalTrials.gov: NCT04087096 ↗Enrolled (actual)
36
Serious AEs
16.7%
Results posted
Oct 2025
Primary outcome: Primary: Percentage Change in Total Hip Bone Mineral Density — 0.60; -6.44 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Denosumab (Drug); Placebo (Drug); Zoledronic Acid (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Total Hip Bone Mineral Density |
0.60; -6.44 | — |
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.
Eligibility Criteria
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) 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
Data sourced from ClinicalTrials.gov (NCT04087096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.