Bone Quality Lyon Orleans
QUALYOR
Bone Quality and Improvement of Fracture Risk Prediction
1 other identifier
observational
1,605
1 country
2
Brief Summary
QUALYOR is a prospective study on the predictive value for fragility fracture of various new techniques assessing bone quality, among postmenopausal women with low bone mass.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2010
CompletedFirst Posted
Study publicly available on registry
June 24, 2010
CompletedStudy Start
First participant enrolled
September 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJuly 7, 2017
July 1, 2017
6.4 years
June 23, 2010
July 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fragility fracture
Appearance of vertebral or non-vertebral fracture during the 4 years follow-up
4 years
Study Arms (1)
Osteopenic women
Women with osteopenia: Bone Mineral Density T-score between -1.0 and -2.5 (for whom with clinical factor risk) or -3.0 (for whom without clinical factor risk)
Interventions
realisation of following exams to evaluate fracture risk in osteopenic women: * hip and wrist Dual energy X-ray Absorptiometry (DXA) * wrist and shin High-Resolution peripheral Quantitative Computed-Tomography(HR-pQCT) * hip Quantitative Computed Tomography (QCT) * High Resolution Digital X-Ray of calcaneum using BMA(tm) system * low-dose stereoradiography using EOS(tm) system (only for a sub-group of 60 voluntary subjects)
Eligibility Criteria
50 years old or older women with lowered Bone Mineral Density
You may qualify if:
- or older women
- post-menopausal since at least one year
- with osteopenia (T-score between -1.0 and -2.5 (with clinical factor risk) or -3.0 (without clinical factor risk)
You may not qualify if:
- corticosteroid therapy \> 3 months, at least 7.5mg/day equivalent prednisolon (stopped since at least 1 year)
- osteoporosis treatment antecedent
- fragility fracture antecedent
- on going post-menopausal hormonal treatment
- clinical signs of hepatic, cardiac or respiratory insufficiency, diseases possibly affecting bone metabolism
- life expectancy \< 4 years, mental or serious illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospices Civils de Lyon
Lyon, France
Centre Hospitalier d'Orléans
Orléans, France
Related Publications (1)
Chapurlat R, Pialat JB, Merle B, Confavreux E, Duvert F, Fontanges E, Khacef F, Peres SL, Schott AM, Lespessailles E. The QUALYOR (QUalite Osseuse LYon Orleans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design. Arch Osteoporos. 2017 Dec 27;13(1):2. doi: 10.1007/s11657-017-0412-6.
PMID: 29282548DERIVED
Biospecimen
Frozen plasma: for later genetic studies Frozen serum: for later studies on new potential marker of bone remodelling
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland CHAPURLAT, MD, PhD
Hospices Civils de Lyon
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2010
First Posted
June 24, 2010
Study Start
September 20, 2010
Primary Completion
February 20, 2017
Study Completion
May 1, 2025
Last Updated
July 7, 2017
Record last verified: 2017-07