Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS)

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation; Evaluation of Expected Bone Loss After Bariatric Surgery

Treatments: Drug: Calciferol, calcium carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT01739855

Vinforce-015

Vinforce 015 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Calcium/Vitamin D

Active Comparator group

Description:

All subjects will receive calcium/vitamin D supplementation after laparoscopic bariatric gastric bypass surgery as follows: daily: 500 mg oral calcium (calcium carbonate) weekly: 16.000 IU oral vitamin D3 (calciferol)

Treatment:

Drug: Calciferol, calcium carbonate

No Calcium/Vitamin D

No Intervention group

Description:

All subjects will not receive calcium/vitamin D supplementation after laparoscopic bariatric gastric bypass surgery.