Bone Quality Lyon Orleans

Hospices Civils de Lyon1,605 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,605

Conditions

Osteopenic Women

Interventions

Bone quality complementary examsOTHER

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

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospices Civils de Lyon

Lyon, France

Centre Hospitalier d'Orléans

Orléans, France

Outcomes

Primary Outcomes

Fragility fracture

Appearance of vertebral or non-vertebral fracture during the 4 years follow-up

Time frame: 4 years

Data from ClinicalTrials.gov

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