Bone Quality Lyon Orleans
Active, not recruiting
- Conditions
- Osteopenic Women
- Registration Number
- NCT01150032
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1605
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fragility fracture 4 years Appearance of vertebral or non-vertebral fracture during the 4 years follow-up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hospices Civils de Lyon
🇫🇷Lyon, France
Centre Hospitalier d'Orléans
🇫🇷Orléans, France
Hospices Civils de Lyon🇫🇷Lyon, France