Evaluation of Expected Bone Loss After Bariatric SurgeryPhase 2BABSNCT01739855
Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS)
A Phase 2 study testing Calciferol, calcium carbonate in people with Evaluation of Expected Bone Loss After Bariatric Surgery and Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Evaluation of Expected Bone Loss After Bariatric Surgery, Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation
- What is being tested?
- Calciferol, calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2012to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index >35
- female and male patients
- age 18 - 65 years
- eligible for laparoscopic gastric bypass surgery according to the Austrian national guidelines
Who cannot join
- any history of malignancy except basalioma
- any prior antiresorptive treatment
- any prior calcium or vitamin D supplementation
- any secondary disease affecting bone metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the 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.
- Conditions
- Evaluation of Expected Bone Loss After Bariatric Surgery, Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation
- Being tested
- Calciferol, calcium carbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calciferol, calcium carbonateDrug
| Study group | Role | What they receive |
|---|---|---|
| Calcium/Vitamin D | Active comparator | 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) Receives: Drug: Calciferol, calcium carbonate |
| No Calcium/Vitamin D | No intervention | All subjects will not receive calcium/vitamin D supplementation after laparoscopic bariatric gastric bypass surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Evaluation every 6 months for 24 months
Secondary outcomes (1)
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
Measured: Evaluation every 3 months for 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Expected Bone Loss After Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Muschitz, Medical University of Vienna
- Investigators
- Christian Muschitz, M.D., Principal investigator, Medical University Vienna - Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739855
- Sponsor's protocol ID
- Vinforce-015
- Other IDs
- Vinforce 015
- Acronym
- BABS
- Status last verified
- Aug 2014
- First submitted
- 23 Nov 2012
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26350034
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Patients Undergoing Bariatric Surgery (Laparoscopic Gastric Bypass) and Evaluation of Bone Metabolism With/Without Vitamin D/Calcium Supplementation
- ClinicalTrials.gov ID
- NCT01739855
- Acronym / sponsor ID
- BABS / Vinforce-015
- Conditions
- Evaluation of Expected Bone Loss After Bariatric Surgery, Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium/Vitamin D | Active comparator | Drug: Calciferol, calcium carbonateAll 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) |
| No Calcium/Vitamin D | No intervention | –All subjects will not receive calcium/vitamin D supplementation after laparoscopic bariatric gastric bypass surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- body mass index >35
- female and male patients
- age 18 - 65 years
- eligible for laparoscopic gastric bypass surgery according to the Austrian national guidelines
Key exclusion criteria (4 listed)
- any history of malignancy except basalioma
- any prior antiresorptive treatment
- any prior calcium or vitamin D supplementation
- any secondary disease affecting bone metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calciferol, calcium carbonate | Drug | Calcium/Vitamin D |
Primary outcome
Evaluation of bone mineral density changes in obese patients after laparoscopic bariatric surgery
Time frame: Evaluation every 6 months for 24 months
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
1 secondary outcome
Evaluation of changes of serum bone turnover markers in obese patients after laparoscopic bariatric surgery
Time frame: Evaluation every 3 months for 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- Derived from this study: PubMed 26350034Muschitz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Muschitz, M.D. principal investigator
Medical University Vienna - Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calciferol, calcium carbonate in people with Evaluation of Expected Bone Loss After Bariatric Surgery and Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of bone mineral density changes in obese patients after laparoscopic bariatric surgery (time frame: Evaluation every 6 months for 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.