Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery (NCT04087096) | Clinical Trial Compass
CompletedPhase 4
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
United States36 participantsStarted 2020-08-24
Plain-language 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.
Who can participate
Age range25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percentage Change in Total Hip Bone Mineral Density
Timeframe: Pre-operative baseline to post-operative month 19