Evaluation of Expected Bone Loss After Bariatric Surgery Clinical Trial
— BABSOfficial 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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | August 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - body mass index >35 - female and male patients - age 18 - 65 years - eligible for laparoscopic gastric bypass surgery according to the Austrian national guidelines Exclusion Criteria: - any history of malignancy except basalioma - any prior antiresorptive treatment - any prior calcium or vitamin D supplementation - any secondary disease affecting bone metabolism |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Evaluation of histomorphometric and histologic changes in obese patients after laparoscopic bariatric surgery | Transiliac bone biopsies will be performed in a approximately 15% of patients at baseline and after 24 months. The following parameters will be measured: bone volume (BV/TV), bone surface (BS/BV), osteoblast surface (OS/BS), trabecular number (TbN), trabecular thickness (TbTh, trabecular separation (Tb.sp), mineralized surface (MS/BS), mineral apposition rate (MAR) Differences will be evaluated on the outcome with/without daily calcium (500mg) and weekly vitamin D (16.000 IU colecalciferol) supplementation |
baseline and after 24 months | Yes |
| Primary | Evaluation of bone mineral density changes in obese patients after laparoscopic bariatric surgery | Dual energy X-ray absorptiometry (DXA) measurements of bone mineral density at lumbar spine, hip, calcaneus and total body will be performed at baseline and every six months for a period of 24 months. Differences will be evaluated on the outcome with/without daily calcium (500mg) and weekly vitamin D (16.000 IU calciferol) supplementation |
Evaluation every 6 months for 24 months | Yes |
| Secondary | Evaluation of changes of serum bone turnover markers in obese patients after laparoscopic bariatric surgery | Fasting serum markers of bone formation and bone resorption will be evaluated: Calcium, 25-OH-vitamin D3, intact parathyroid hormone, beta-crosslaps, type-1-procollagen, bone specific alkaline phosphatase, osteocalcin, sclerostin, osteoprotegerin, cathepsin-K, fibroblast factor 23, lipoprotein A, dickkopf 1 Differences will be evaluated on the outcome with/without daily calcium (500mg) and weekly vitamin D (16.000 IU calciferol) supplementation |
Evaluation every 3 months for 24 months | Yes |