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Bone Quality Lyon Orleans (QUALYOR)

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ClinicalTrials.gov Identifier: NCT01150032
Recruitment Status : Active, not recruiting
First Posted : June 24, 2010
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteopenic Women Other: Bone quality complementary exams

Study Type : Observational
Actual Enrollment : 1605 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Quality and Improvement of Fracture Risk Prediction
Actual Study Start Date : September 20, 2010
Actual Primary Completion Date : February 20, 2017
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. Fragility fracture [ Time Frame: 4 years ]
    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


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01150032     History of Changes
Other Study ID Numbers: 2009.588
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

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