Bone Quality Lyon Orleans (QUALYOR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01150032
First received: June 23, 2010
Last updated: January 17, 2013
Last verified: December 2010
  Purpose

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.


Condition Intervention
Osteopenic Women
Other: Bone quality complementary exams

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Quality and Improvement of Fracture Risk Prediction

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Fragility fracture [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Appearance of vertebral or non-vertebral fracture during the 4 years follow-up


Biospecimen Retention:   Samples With DNA

Frozen plasma: for later genetic studies Frozen serum: for later studies on new potential marker of bone remodelling


Enrollment: 1605
Study Start Date: September 2010
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Osteopenic women
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)
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)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

50 years old or older women with lowered Bone Mineral Density

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150032

Locations
France
Hospices Civils de Lyon
Lyon, France
Centre Hospitalier d'Orléans
Orléans, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Roland CHAPURLAT, MD, PhD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01150032     History of Changes
Other Study ID Numbers: 2009.588
Study First Received: June 23, 2010
Last Updated: January 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Osteoporosis
Fracture
Bone microarchitecture

ClinicalTrials.gov processed this record on September 30, 2014