Clinical trial NCT01739855: Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS)
Official title: Phase 2 Study of Patients Undergoing Bariatric Surgery (Laparoscopic Gastric Bypass) and Evaluation of Bone Metabolism With/Without Vitamin D/Calcium Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Evaluation of Expected Bone Loss After Bariatric Surgery
Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of bone mineral density changes in obese patients after laparoscopic bariatric surgery
timeFrame: Evaluation every 6 months for 24 months
Secondary outcomes:
measure: Evaluation of changes of serum bone turnover markers in obese patients after laparoscopic bariatric surgery
timeFrame: Evaluation every 3 months for 24 months
Other outcomes:
measure: Evaluation of histomorphometric and histologic changes in obese patients after laparoscopic bariatric surgery
timeFrame: baseline and after 24 months
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University Vienna - Austria
name: Christian Muschitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muschitz C, Kocijan R, Haschka J, Zendeli A, Pirker T, Geiger C, Muller A, Tschinder B, Kocijan A, Marterer C, Nia A, Muschitz GK, Resch H, Pietschmann P. The Impact of Vitamin D, Calcium, Protein Supplementation, and Physical Exercise on Bone Metabolism After Bariatric Surgery: The BABS Study. J Bone Miner Res. 2016 Mar;31(3):672-82. doi: 10.1002/jbmr.2707. Epub 2015 Sep 30.