Evaluation of Expected Bone Loss After Bariatric Surgery Clinical Trial
Official title:
Phase 2 Study of Patients Undergoing Bariatric Surgery (Laparoscopic Gastric Bypass) and Evaluation of Bone Metabolism With/Without Vitamin D/Calcium Supplementation
Bariatric surgery leads to rapid weight loss in female and male patients. Less data are
available about its impact on bone metabolism.
The aim of this study is the investigation of changes in bone mineral density,bone
histomorphometric changes, serum bone turnover markers and changes in body fat and muscle
composition in patients after laparoscopic gastric bypass surgery.
Obese female and male adult patients eligible for laparoscopic gastric bypass surgery
according to the national Austrian guidelines will be included in this study upon request
and after patient approval.
Baseline data collection and quarterly follow up visits are planned to investigate the
changes in bone mineral density and body composition measured by dual energy X-ray
absorptiometry as well as the evaluation of serum bone turnover markers of bone formation
and resorption.
After surgery subjects will be randomized into two groups:
Daily oral calcium (500mg) and weekly vitamin D3 supplementation (16.000 IU calciferol)or no
supplementation of calcium and calciferol.
A sub-study (approximately 15% of study population) with transiliac bone biopsies will also
be performed to investigate histomorphometric and histologic changes in bone (biopsy
baseline and after 24 months).
The planned duration of the study is 24 months for each subject. Serum bone turnover markers
will be collected every 3 months, dual energy X-ray absorptiometry measurements will be
performed every 6 months.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment