AzTrials
AzTrials

ObesityNCT04174495

Bone Fragility Evaluation in Obese Patients

An observational study of Obesity and Bariatric Surgery Candidate, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research will study the bone fragility in obese patients, on DXA and CT-scan, in a transversal study. The investigators want also to study the specific risk factors of bone fragility in these obese patients (relationship between body composition on whole body on DXA, fat mass and its location, lean mass, weight… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Bariatric Surgery Candidate
What is being tested?
DXA and CT-scan
How many people
1,500 participants
Where
1 siteFrance
Study dates
23 Feb 2020to 23 Aug 2021
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: obese patients followed before a bariatric surgery, at Nancy university hospital who performed a CT-scan and DXA, usually performed before surgery, with a delay which did not exceed 1 year before the 2 exams

Who may be able to join

  • patients followed at Nancy university hospital for a bariatric surgery
  • CT-scan and DXA performed before surgery, with maximum 1 year before the 2 exams

Who cannot join

  • < 18 years
  • Protected adults

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nancy university hosiptal

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: Bone Fragility Evaluation by Dual X-Ray Absorptiometry (DXA) and CT-scan (vertebral Fracture and Scanographic Bone Attenuation Coefficient of the First Lumbar Vertebra SBAC-L1) in Obese Patients

This research will study the bone fragility in obese patients, on DXA and CT-scan, in a transversal study. The investigators want also to study the specific risk factors of bone fragility in these obese patients (relationship between body composition on whole body on DXA, fat mass and its location, lean mass, weight loss after surgery and SBAC-L1), to improve the bone screening.

Being tested
DXA and CT-scan
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DXA and CT-scanDiagnostic test

    DXA and CT-scan are usually performed during the following of these patients before bariatric surgery

Study groups in NCT04174495
Study groupRoleWhat they receive
Obese patients followed at Nancy University HospitalNot described
Receives: Diagnostic Test: DXA and CT-scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. scanographic bone attenuation coefficient of the first lumbar vertebra SBAC-L1

    on axial section of the first lumbar vertebra, with a region of interest

    Measured: November 2019-September 2020

Secondary outcomes (4)

  1. Vertebral fracture

    According Genant classification, on sagittal section of spine

    Measured: November 2019-September 2020

  2. DXA: T-score

    in standard deviation, on spine / hip / femoral neck / wrist

    Measured: November 2019-September 2020

  3. DXA: Bone mineral density BMD (spine, hip , femoral neck, wrist)

    in g/cm²

    Measured: November 2019-September 2020

  4. DXA: lean and fat mass

    in % and repartition of each

    Measured: November 2019-September 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2019
  2. Study start23 Feb 2020
  3. Primary completion20 Aug 2021
  4. Study completion23 Aug 2021

Resources

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
Retrospective
Enrolment
1,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04174495
Sponsor's protocol ID
2019PI216
Status last verified
Aug 2021
First submitted
16 Nov 2019
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Murray TE, Williams D, Lee MJ. Osteoporosis, obesity, and sarcopenia on abdominal CT: a review of epidemiology, diagnostic criteria, and management strategies for the reporting radiologist. Abdom Radiol (NY). 2017 Sep;42(9):2376-2386. doi: 10.1007/s00261-017-1124-5.

    PubMed 28386693

  • Walsh JS, Vilaca T. Obesity, Type 2 Diabetes and Bone in Adults. Calcif Tissue Int. 2017 May;100(5):528-535. doi: 10.1007/s00223-016-0229-0. Epub 2017 Mar 9.

    PubMed 28280846

  • Hammoud E, Toumi H, Jacob C, Pinti A, Lespessailles E, El Hage R. Does the Severity of Obesity Influence Bone Mineral Density Values in Premenopausal Women? J Clin Densitom. 2021 Apr-Jun;24(2):225-232. doi: 10.1016/j.jocd.2019.04.006. Epub 2019 Apr 26.

    PubMed 31109773

  • Bauer JM, Cruz-Jentoft AJ, Fielding RA, Kanis JA, Reginster JY, Bruyere O, Cesari M, Chapurlat R, Al-Daghri N, Dennison E, Kaufman JM, Landi F, Laslop A, Locquet M, Maggi S, McCloskey E, Perna S, Rizzoli R, Rolland Y, Rondanelli M, Szulc P, Vellas B, Vlaskovska M, Cooper C. Is There Enough Evidence for Osteosarcopenic Obesity as a Distinct Entity? A Critical Literature Review. Calcif Tissue Int. 2019 Aug;105(2):109-124. doi: 10.1007/s00223-019-00561-w. Epub 2019 May 16.

    PubMed 31098729

  • Jammah AA. Endocrine and metabolic complications after bariatric surgery. Saudi J Gastroenterol. 2015 Sep-Oct;21(5):269-77. doi: 10.4103/1319-3767.164183.

    PubMed 26458852

  • Hong CS, Bergen MA, Watters TS. Transient osteoporosis of the hip after bariatric surgery. Arthroplast Today. 2018 Dec 7;5(1):32-37. doi: 10.1016/j.artd.2018.10.010. eCollection 2019 Mar.

    PubMed 31020018

  • Lespessailles E, Hammoud E, Toumi H, Ibrahim-Nasser N. Consequences of bariatric surgery on outcomes in rheumatic diseases. Arthritis Res Ther. 2019 Mar 28;21(1):83. doi: 10.1186/s13075-019-1869-z.

    PubMed 30922375

  • Santos D, Lopes T, Jesus P, Cruz S, Cordeiro A, Pereira S, Saboya C, Ramalho A. Bone Metabolism in Adolescents and Adults Undergoing Roux-En-Y Gastric Bypass: a Comparative Study. Obes Surg. 2019 Jul;29(7):2144-2150. doi: 10.1007/s11695-019-03797-5.

    PubMed 30820885

  • Geoffroy M, Charlot-Lambrecht I, Chrusciel J, Gaubil-Kaladjian I, Diaz-Cives A, Eschard JP, Salmon JH. Impact of Bariatric Surgery on Bone Mineral Density: Observational Study of 110 Patients Followed up in a Specialized Center for the Treatment of Obesity in France. Obes Surg. 2019 Jun;29(6):1765-1772. doi: 10.1007/s11695-019-03719-5.

    PubMed 30734230

  • Madsen LR, Espersen R, Ornstrup MJ, Jorgensen NR, Langdahl BL, Richelsen B. Bone Health in Patients with Type 2 Diabetes Treated by Roux-En-Y Gastric Bypass and the Role of Diabetes Remission. Obes Surg. 2019 Jun;29(6):1823-1831. doi: 10.1007/s11695-019-03753-3.

    PubMed 30719648

  • Axelsson KF, Werling M, Eliasson B, Szabo E, Naslund I, Wedel H, Lundh D, Lorentzon M. Fracture Risk After Gastric Bypass Surgery: A Retrospective Cohort Study. J Bone Miner Res. 2018 Dec;33(12):2122-2131. doi: 10.1002/jbmr.3553. Epub 2018 Aug 13.

    PubMed 30011091

  • Mesureur L, Arvanitakis M. Metabolic and nutritional complications of bariatric surgery : a review. Acta Gastroenterol Belg. 2017 Oct-Dec;80(4):515-525.

    PubMed 29560648

  • Kalani A, Bami H, Tiboni M, Jaeschke R, Adachi JD, Lau AN. The effect of bariatric surgery on serum 25-OH vitamin D levels: a systematic review and meta-analysis. Obes Sci Pract. 2017 Jun 27;3(3):319-332. doi: 10.1002/osp4.113. eCollection 2017 Sep.

    PubMed 29071108

  • Cook FJ, Khanna I, Giordano J, Matarese L, Hudson S. LONG-TERM BONE HEALTH AFTER ROUX-EN-Y GASTRIC BYPASS: A PILOT STUDY. Endocr Pract. 2017 Sep;23(9):1077-1084. doi: 10.4158/EP171823.OR. Epub 2017 Jul 6.

    PubMed 28683234

  • Shanbhogue VV, Stoving RK, Frederiksen KH, Hanson S, Brixen K, Gram J, Jorgensen NR, Hansen S. Bone structural changes after gastric bypass surgery evaluated by HR-pQCT: a two-year longitudinal study. Eur J Endocrinol. 2017 Jun;176(6):685-693. doi: 10.1530/EJE-17-0014. Epub 2017 Mar 13.

    PubMed 28289103

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Bariatric Surgery Candidate, run by Central Hospital, Nancy, France 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 2 inclusion and 2 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 24 Feb 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 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?

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?

scanographic bone attenuation coefficient of the first lumbar vertebra SBAC-L1 (time frame: November 2019-September 2020). 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 NCT04174495, which also lists 20 linked publications.

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 24 Feb 2025.

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