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Bone Quality Lyon Orleans

Bone Quality and Improvement of Fracture Risk Prediction

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01150032
Acronym
QUALYOR
Enrollment
1605
Registered
2010-06-24
Start date
2010-09-20
Completion date
2025-05-31
Last updated
2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenic Women

Keywords

Osteoporosis, Fracture, Bone microarchitecture

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.

Interventions

OTHERBone quality complementary exams

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)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 50 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Fragility fracture4 yearsAppearance of vertebral or non-vertebral fracture during the 4 years follow-up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026