Bariatric Surgery in Postmenopausal WomenADIMOS-OBNCT05005039
Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss
An observational study of Bariatric Surgery in Postmenopausal Women, run by University Hospital, Lille at 1 site in France.
Trial summary
Results are inconsistent and further studies are needed to better understand the impact of bariatric surgery on the bone-BMA relationship depending on the type of bariatric surgery: RYGB vs. SG. Future studies are also needed to define the molecular mediators of bone loss and BMA changes. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Bariatric Surgery in Postmenopausal Women
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2022to Jun 2027
- 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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Sample population will be 40 postmenopausal women suffering from obesity, candidates for their first bariatric surgery procedure
Who may be able to join
- Postmenopausal women (defined as last menses >12 months)
- Obesity with a BMI ≥ 35 kg/m²,
- Patients with an indication for bariatric surgery with two surgical techniques, RYGB and SG, but who have never had a bariatric surgery procedure previously,
- Patients who have signed the informed consent.
Who cannot join
- History of an osteoporotic fracture 2- Current corticosteroid therapy or corticosteroid therapy within the past 3 months, C-onditions or treatments affecting bone metabolism (breast cancer treated with aromatase inhibitors, malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism…),
- History of radiation therapy to the lumbar spine or the hip being studied,
- Patients on hormone replacement therapy (HRT) or patients already on anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide, or denosumab) other than calcium and/or vitamin D supplementation,
- Chronic kidney disease with a creatinine clearance (CKD-EPI formula) ≤ 30 mL/min,
- Weight > 160 kg, as the bone densitometer table is limited to this weight for the examination,
- Patients who have previously undergone bariatric surgery,
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- Patients with orthopedic implants in both hips or the lumbar spine,
- Individuals unable to give personal consent,
- Individuals under legal guardianship or conservatorship,
- Patients not enrolled in a social security program.
- Any contraindication to MRI: (claustrophobia, patients with a pacemaker/defibrillator, cochlear implant, neurostimulator, or orthopedic implants in the hip, pelvis, or lumbar spine, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Results are inconsistent and further studies are needed to better understand the impact of bariatric surgery on the bone-BMA relationship depending on the type of bariatric surgery: RYGB vs. SG. Future studies are also needed to define the molecular mediators of bone loss and BMA changes. Several molecular mediators have been considered including gut hormones, adipokines, gonadal hormones and more recently G-CSF. However, the evidence to support any of these alone or in combination as primary mechanisms of bone loss is scant.
The study will be to explore potential changes in BMA after bariatric surgery and search for possible associated factors. Specifically, we want to investigate if such changes in BMFF differed in participants among different surgical types (RYGB vs. SG) and diabetic status. Secondly, we want to explore factors associated with BMFF changes including metabolic homeostasis (glycemic control and blood lipid levels), adipokines (leptin and adiponectin), calciotropic hormones (Ca++, PTH…), body composition parameters and bone markers (cross-laps, P1NP and sclerostin). We hypothesize that the BMFF would particularly decrease after RYGB compared to SG and that participants with T2D would have a larger decrease in BMFF than participants without T2D.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese postmenopausal women who will undergo RYGB | Not described | |
| Obese postmenopausal women who will undergo SG | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in bone marrow fat fraction (BMFF) in %
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start20 Apr 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery in Postmenopausal WomenStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien PACCOU, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005039
- Sponsor's protocol ID
- 2021_0045
- Other IDs
- 2021-A01440-41
- Acronym
- ADIMOS-OB
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2021
- Last updated
- 20 Apr 2026
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss
- ClinicalTrials.gov ID
- NCT05005039
- Acronym / sponsor ID
- ADIMOS-OB / 2021_0045
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Aug 2021 (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.
Results are inconsistent and further studies are needed to better understand the impact of bariatric surgery on the bone-BMA relationship depending on the type of bariatric surgery: RYGB vs. SG. Future studies are also needed to define the molecular mediators of bone loss and BMA changes. Several molecular mediators have been considered including gut hormones, adipokines, gonadal hormones and more recently G-CSF. However, the evidence to support any of these alone or in combination as primary mechanisms of bone loss is scant.
The study will be to explore potential changes in BMA after bariatric surgery and search for possible associated factors. Specifically, we want to investigate if such changes in BMFF differed in participants among different surgical types (RYGB vs. SG) and diabetic status. Secondly, we want to explore factors associated with BMFF changes including metabolic homeostasis (glycemic control and blood lipid levels), adipokines (leptin and adiponectin), calciotropic hormones (Ca++, PTH…), body composition parameters and bone markers (cross-laps, P1NP and sclerostin). We hypothesize that the BMFF would particularly decrease after RYGB compared to SG and that participants with T2D would have a larger decrease in BMFF than participants without T2D.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese postmenopausal women who will undergo RYGB | – | – |
| Obese postmenopausal women who will undergo SG | – | – |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample population will be 40 postmenopausal women suffering from obesity, candidates for their first bariatric surgery procedure
Key inclusion criteria (4 listed)
- Postmenopausal women (defined as last menses >12 months)
- Obesity with a BMI ≥ 35 kg/m²,
- Patients with an indication for bariatric surgery with two surgical techniques, RYGB and SG, but who have never had a bariatric surgery procedure previously,
- Patients who have signed the informed consent.
Key exclusion criteria (11 listed)
- History of an osteoporotic fracture 2- Current corticosteroid therapy or corticosteroid therapy within the past 3 months, C-onditions or treatments affecting bone metabolism (breast cancer treated with aromatase inhibitors, malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism…),
- History of radiation therapy to the lumbar spine or the hip being studied,
- Patients on hormone replacement therapy (HRT) or patients already on anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide, or denosumab) other than calcium and/or vitamin D supplementation,
- Chronic kidney disease with a creatinine clearance (CKD-EPI formula) ≤ 30 mL/min,
- Weight > 160 kg, as the bone densitometer table is limited to this weight for the examination,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation in bone marrow fat fraction (BMFF) in %
Time frame: 12 months
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 20 Apr 2026.
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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.
Julien PACCOU, MD,PhD principal investigator
University Hospital, Lille
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 in Postmenopausal Women, run by University Hospital, Lille at 1 site in France.
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 11 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 20 Apr 2026. 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 France. 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 Julien PACCOU, MD,PhD (0320445962 ext. +33, julien.paccou@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in bone marrow fat fraction (BMFF) in % (time frame: 12 months). 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 20 Apr 2026.