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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2010

Last Updated Date

January 17, 2013

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

February 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fragility fracture [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Appearance of vertebral or non-vertebral fracture during the 4 years follow-up

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01150032 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bone Quality Lyon Orleans

Official Title ^ICMJE

Bone Quality and Improvement of Fracture Risk Prediction

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

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

Sampling Method

Non-Probability Sample

Study Population

50 years old or older women with lowered Bone Mineral Density

Condition ^ICMJE

Osteopenic Women

Intervention ^ICMJE

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)

Study Group/Cohort (s)

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)

Intervention: Other: Bone quality complementary exams

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

1605

Estimated Completion Date

February 2017

Estimated Primary Completion Date

February 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01150032

Other Study ID Numbers ^ICMJE

2009.588

Has Data Monitoring Committee

Responsible Party

Hospices Civils de Lyon

Study Sponsor ^ICMJE

Hospices Civils de Lyon

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Roland CHAPURLAT, MD, PhD

Hospices Civils de Lyon

Information Provided By

Hospices Civils de Lyon

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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