This trial is active, not recruiting.

Condition osteopenic women
Treatment bone quality complementary exams
Sponsor Hospices Civils de Lyon
Start date September 2010
End date February 2017
Trial size 1605 participants
Trial identifier NCT01150032, 2009.588


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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)
bone 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)

Primary Outcomes

Fragility fracture
time frame: 4 years

Eligibility Criteria

Female participants at least 50 years old.

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

Additional Information

Official title Bone Quality and Improvement of Fracture Risk Prediction
Principal investigator Roland CHAPURLAT, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.