Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stinus Gadegaard Hansen
• Collaborators: Department of Endocrinology, Odense University Hospital, Odense, Denmark; Department of Radiology and Nuclear Medicine, Hospital of Southwest Jutland, 6700 Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark; Odense University Hospital; OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark; Research Unit of Health Sciences, Hospital of South West Jutland
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

• 35 years old or older

• Eligible for bariatric surgery (BMI>35 kg/m2 with obesity-related comorbidity)

Exclusion Criteria:

• Pregnancy or breastfeeding.

• Chronic kidney disease with estimated GFR<45 ml/min.

• Hypocalcemia .

• Hypersensitivity to bisphosphonates, mannitol, sodium citrate or water.

• Metabolic bone disease (osteoporosis is allowed).

• Prior treatment with anti-osteoporotic agents.

• Treatment with oral glucocorticoids

• Other diseases with known effects on bone metabolism