Bone Quality Lyon Orleans (QUALYOR)

Civil Hospices of Lyon

Status: Active, not recruiting

Conditions: Osteopenic Women

Treatments: Other: Bone quality complementary exams

Study type: Observational

Funder types: Other

Identifiers

NCT01150032

2009.588

Details and patient eligibility

About

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.

Enrollment: 1,605 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,605 participants in 1 patient group

Osteopenic women

Description:

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)

Treatment:

Other: Bone quality complementary exams