Bone Quality Lyon Orleans

Osteopenic Women Clinical Trial

— QUALYOR  

Official title:

Bone Quality and Improvement of Fracture Risk Prediction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01150032
• Other study ID #: 2009.588
• Status: Active, not recruiting
• Phase: N/A
• First received: June 23, 2010
• Last updated: July 6, 2017
• Start date: September 20, 2010
• Est. completion date: May 2025

Study information

• Verified date: July 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1605
• Est. completion date: May 2025
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteopenic Women

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon
France	Centre Hospitalier d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fragility fracture	Appearance of vertebral or non-vertebral fracture during the 4 years follow-up	4 years