Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Calcium/Vitamin D

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)

Group Type ACTIVE_COMPARATOR

Calciferol, calcium carbonate

Intervention Type DRUG

No Calcium/Vitamin D

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Calciferol, calcium carbonate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No