Bariatric SurgeryBONUSNCT06547515
Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
An observational study of Bariatric Surgery and Bone Health, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Bone Health, Severe Obesity
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- 14 Sep 2022to 15 Aug 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a multicentre, prospective and observational study comprising a SG bariatric group undergoing SG (n=117) comprising an equal number of men, premenopausal and postmenopausal women (n=39/group) meeting the inclusion/exclusion criteria, and assessed before, and at one and 3 years after SG. An obese non-surgical group (n=39; 13 men, premenopausal and postmenopausal women) meeting the criteria for SG but who will not undergo surgery during the 3-year period following recruitment will be assessed using the same tests and at the same timepoints.
Who may be able to join
- Men and women aged >18 years;
- Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group.
- Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) >40 UI/L.
- Women taking oral contraceptive pills or hormone replacement therapy
- Patients with type 2 diabetes.
Who cannot join
- Type 1 diabetes;
- Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)
- Metabolic bone disease other than osteoporosis or type 2 diabetes,
- Creatinine clearance <30 ml/min) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;
- Weight >204 kg (DXA weight limit) or BMI >60 kg/m2 (upper limit to allow for QCT examination);
- Current or planned pregnancy during follow-up; breast-feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche de l'IUCPQ
Québec, G1V 4G5
Sandrine Hegg-Deloye, 418-525-4444 ext. 48729, sandrine-hegg-deloye@crchudequebec.ulaval.ca
Claudia Gagnon, Dr
About this study
Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.
- Conditions
- Bariatric Surgery, Bone Health, Severe Obesity, Muscle Health
- Being tested
- Bariatric surgery
- Keywords
- bariatric surgery, Bone health, Severe Obesity, Muscle Health
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy - Men | n = 39 men with obesity undergoing sleeve gastrectomy Receives: Procedure: Bariatric surgery | |
| Sleeve gastrectomy - Premenopausal women | n = 39 premenopausal women with obesity undergoing sleeve gastrectomy Receives: Procedure: Bariatric surgery | |
| Sleeve gastrectomy - Postmenopausal women | n = 39 postmenopausal women with obesity undergoing sleeve gastrectomy Receives: Procedure: Bariatric surgery | |
| Obese non-surgical group | n = 39 (13 men, 13 premenopausal and 13 postmenopausal women) obese non-surgical individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vBMD at the spine (L2-L3) and proximal femur
assessed by QCT
Measured: before, 1 year after and 3 years after bariatric surgery
Change in muscle mass at mid-femur
determined by measuring cross-sectional area at mid-femur (CT)
Measured: before, 1 year after and 3 years after bariatric surgery
Secondary outcomes (9)
Change in vBMD at skeletal sites other than the spine
assessed by QCT
Measured: before, 1 year after and 3 years after bariatric surgery
Change in aBMD at skeletal sites
assessed by DXA
Measured: before, 1 year after and 3 years after bariatric surgery
Change in whole body muscle mass
assessed by DXA
Measured: before, 1 year after and 3 years after bariatric surgery
Change in muscle quality at mid-femur
muscle fat infiltration, using CT attenuation in Hounsfield unit (HU)
Measured: before, 1 year after and 3 years after bariatric surgery
Change in muscle strength
assessed by CT
Measured: before, 1 year after and 3 years after bariatric surgery
Change in upper extremity muscle strength
by hand grip strength
Measured: before, 1 year after and 3 years after bariatric surgery
Change in lower extremity muscle strength
knee extensor strength
Measured: before, 1 year after and 3 years after bariatric surgery
Change in muscle mass (muscle cross-sectional area) and function
by timed up and go test
Measured: before, 1 year after and 3 years after bariatric surgery
Change in muscle mass (muscle cross-sectional area) and function
by 6-minute walk test
Measured: before, 1 year after and 3 years after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Sep 2022
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Claudia Gagnon, CHU de Quebec-Universite Laval
- Investigators
- Claudia Gagnon, Dr, Principal investigator, CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547515
- Sponsor's protocol ID
- MP-10-2022-3823
- Acronym
- BONUS
- Status last verified
- Jun 2025
- First submitted
- 25 Jul 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06547515
- Acronym / sponsor ID
- BONUS / MP-10-2022-3823
- Conditions
- Bariatric Surgery, Bone Health, Severe Obesity, Muscle Health
- Keywords
- bariatric surgery, Bone health, Severe Obesity, Muscle Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- 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.
Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy - Men | – | Procedure: Bariatric surgeryn = 39 men with obesity undergoing sleeve gastrectomy |
| Sleeve gastrectomy - Premenopausal women | – | Procedure: Bariatric surgeryn = 39 premenopausal women with obesity undergoing sleeve gastrectomy |
| Sleeve gastrectomy - Postmenopausal women | – | Procedure: Bariatric surgeryn = 39 postmenopausal women with obesity undergoing sleeve gastrectomy |
| Obese non-surgical group | – | –n = 39 (13 men, 13 premenopausal and 13 postmenopausal women) obese non-surgical individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multicentre, prospective and observational study comprising a SG bariatric group undergoing SG (n=117) comprising an equal number of men, premenopausal and postmenopausal women (n=39/group) meeting the inclusion/exclusion criteria, and assessed before, and at one and 3 years after SG. An obese non-surgical group (n=39; 13 men, premenopausal and postmenopausal women) meeting the criteria for SG but who will not undergo surgery during the 3-year period following recruitment will be assessed using the same tests and at the same timepoints.
Key inclusion criteria (5 listed)
- Men and women aged >18 years;
- Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group.
- Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) >40 UI/L.
- Women taking oral contraceptive pills or hormone replacement therapy
- Patients with type 2 diabetes.
Key exclusion criteria (6 listed)
- Type 1 diabetes;
- Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)
- Metabolic bone disease other than osteoporosis or type 2 diabetes,
- Creatinine clearance <30 ml/min) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;
- Weight >204 kg (DXA weight limit) or BMI >60 kg/m2 (upper limit to allow for QCT examination);
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 |
|---|---|---|
| Bariatric surgerySleeve gastrectomy | Procedure or surgery | Sleeve gastrectomy - Men, Sleeve gastrectomy - Postmenopausal women, Sleeve gastrectomy - Premenopausal women |
Primary outcome
Change in vBMD at the spine (L2-L3) and proximal femur
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by QCT
Change in muscle mass at mid-femur
Time frame: before, 1 year after and 3 years after bariatric surgery
determined by measuring cross-sectional area at mid-femur (CT)
9 secondary outcomes
Change in vBMD at skeletal sites other than the spine
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in aBMD at skeletal sites
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in whole body muscle mass
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in muscle quality at mid-femur
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in muscle strength
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in upper extremity muscle strength
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in lower extremity muscle strength
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in muscle mass (muscle cross-sectional area) and function
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in muscle mass (muscle cross-sectional area) and function
Time frame: before, 1 year after and 3 years after bariatric surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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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.
Claudia Gagnon, Dr principal investigator
CHU de Québec - Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Bone Health, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. 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 Canada. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine Hegg-Deloye, PhD (4185254444 ext. 48729, sandrine.hegg-deloye@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vBMD at the spine (L2-L3) and proximal femur (time frame: before, 1 year after and 3 years after bariatric surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.