Status:
UNKNOWN
Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)
Lead Sponsor:
Stinus Gadegaard Hansen
Collaborating Sponsors:
Research Unit of Health Sciences, Hospital of South West Jutland
Department of Regional Health Research, University of Southern Denmark
Conditions:
Bone Loss
Muscle Atrophy
Eligibility:
All Genders
35+ years
Phase:
PHASE2
Brief Summary
In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.
Detailed Description
In individuals with severe obesity, bariatric surgery effectively reduces body weight, improves obesity related diseases and lowers mortality. A loss of bone and muscle mass and an increase in bone fr...
Eligibility Criteria
Inclusion
- 35 years old or older
- Eligible for bariatric surgery (BMI\>35 kg/m2 with obesity-related comorbidity)
Exclusion
- 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
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04742010
Start Date
February 20 2021
End Date
June 1 2024
Last Update
June 10 2022
Active Locations (1)
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1
Hospital South West Jutland
Esbjerg, Denmark, 6700