Osteopenic WomenQUALYORNCT01150032
Bone Quality Lyon Orleans
An observational study of Osteopenic Women, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteopenic Women
- What is being tested?
- Bone quality complementary exams
- How many people
- 1,605 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Sep 2010to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 50 years old or older women with lowered Bone Mineral Density
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Osteopenic Women
- Being tested
- Bone quality complementary exams
- Keywords
- Osteoporosis, Fracture, Bone microarchitecture
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone quality complementary examsOther
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 | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Bone quality complementary exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fragility fracture
Appearance of vertebral or non-vertebral fracture during the 4 years follow-up
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study start20 Sep 2010
- Primary completion20 Feb 2017
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteopenic WomenStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland CHAPURLAT, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150032
- Sponsor's protocol ID
- 2009.588
- Acronym
- QUALYOR
- Status last verified
- Jul 2017
- First submitted
- 23 Jun 2010
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chapurlat R, Pialat JB, Merle B, Confavreux E, Duvert F, Fontanges E, Khacef F, Peres SL, Schott AM, Lespessailles E. The QUALYOR (QUalite Osseuse LYon Orleans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design. Arch Osteoporos. 2017 Dec 27;13(1):2. doi: 10.1007/s11657-017-0412-6.
PubMed 29282548
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Quality and Improvement of Fracture Risk Prediction
- ClinicalTrials.gov ID
- NCT01150032
- Acronym / sponsor ID
- QUALYOR / 2009.588
- Conditions
- Osteopenic Women
- Keywords
- Osteoporosis, Fracture, Bone microarchitecture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,605 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Sep 2010 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 24 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteopenic women | – | Other: Bone quality complementary examsWomen 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 years old or older women with lowered Bone Mineral Density
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone quality complementary examsrealisation 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) | Other | Osteopenic women |
Primary outcome
Fragility fracture
Time frame: 4 years
Appearance of vertebral or non-vertebral fracture during the 4 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Derived from this study: PubMed 29282548Chapurlat R, Pialat JB, Merle B, Confavreux E, Duvert F, Fontanges E, Khacef F, Peres SL, Schott AM, Lespessailles E. The QUALYOR (QUalite Osseuse LYon Orleans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design. Arch Osteoporos. 2017 Dec 27;13(1):2. doi: 10.1007/s11657-017-0412-6.
Related trials for Osteopenic Women
Recruiting
Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women
Low Back Pain, Osteopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland CHAPURLAT, MD, PhD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteopenic Women, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fragility fracture (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.