Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Dr. Christian Muschitz, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01739855
First received: November 23, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Evaluation of Expected Bone Loss After Bariatric Surgery
Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation
Drug: Calciferol, calcium carbonate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Patients Undergoing Bariatric Surgery (Laparoscopic Gastric Bypass) and Evaluation of Bone Metabolism With/Without Vitamin D/Calcium Supplementation

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Evaluation of bone mineral density changes in obese patients after laparoscopic bariatric surgery [ Time Frame: Evaluation every 6 months for 24 months ] [ Designated as safety issue: Yes ]

    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



Secondary Outcome Measures:
  • Evaluation of changes of serum bone turnover markers in obese patients after laparoscopic bariatric surgery [ Time Frame: Evaluation every 3 months for 24 months ] [ Designated as safety issue: Yes ]

    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



Other Outcome Measures:
  • Evaluation of histomorphometric and histologic changes in obese patients after laparoscopic bariatric surgery [ Time Frame: baseline and after 24 months ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 160
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)

Drug: Calciferol, calcium carbonate
No Intervention: No Calcium/Vitamin D
All subjects will not receive calcium/vitamin D supplementation after laparoscopic bariatric 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739855

Locations
Austria
Medical University Vienna Recruiting
Vienna, Austria, 1060
Contact: Christian Muschitz, M.D.    +43159988 ext 2119    christian.muschitz@bhs.at   
Contact: Heinrich Resch, M.D.    +43159988 ext 2119    heinrich.resch@bhs.at   
Principal Investigator: Christian Muschitz, M.D.         
Sub-Investigator: Heinrich Resch, M.D.         
Sub-Investigator: Alexander Klaus, M.D.         
Sub-Investigator: Natascha Tykalsky, M.D.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christian Muschitz, M.D. Medical University Vienna - Austria
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Christian Muschitz, Senior Consultant for Internal Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01739855     History of Changes
Other Study ID Numbers: Vinforce-015, Vinforce 015
Study First Received: November 23, 2012
Last Updated: November 28, 2012
Health Authority: Austria: Institutional Review Board St.Vincent Hospital Vienna

Additional relevant MeSH terms:
Calcium, Dietary
Cholecalciferol
Ergocalciferols
Vitamin D
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014