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Clinical Trials/NCT01150032
NCT01150032
Active, not recruiting
Not Applicable

Bone Quality and Improvement of Fracture Risk Prediction

Hospices Civils de Lyon2 sites in 1 country1,605 target enrollmentSeptember 20, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteopenic Women
Sponsor
Hospices Civils de Lyon
Enrollment
1605
Locations
2
Primary Endpoint
Fragility fracture
Status
Active, not recruiting
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2010
End Date
May 2025
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fragility fracture

Time Frame: 4 years

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

Study Sites (2)

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