Bone Quality Lyon Orleans (QUALYOR)

July 6, 2017 updated by: Hospices Civils de Lyon

Bone Quality and Improvement of Fracture Risk Prediction

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1605

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Hospices Civils de Lyon
      • Orléans, France
        • Centre Hospitalier d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

50 years old or older women with lowered Bone Mineral Density

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fragility fracture
Time Frame: 4 years
Appearance of vertebral or non-vertebral fracture during the 4 years follow-up
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Roland CHAPURLAT, MD, PhD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2010

Primary Completion (Actual)

February 20, 2017

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

June 23, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (Estimate)

June 24, 2010

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 6, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009.588

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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