OsteoporosisARTEOS2NCT01587456
Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort
An observational study of Osteoporosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Apr 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women and men > 60 years of age with medical history of low energy fracture andradiologic osteoporosis with DXA Tscore at -2,5 DS.
Who may be able to join
- women and men > 60 years of age
- medical history of low energy fracture
- DXA Tscore -2,5 DS
- FREE AND INFORMED CONSENT SIGNED
Who cannot join
- women and men < 60 years of age
- Corticoids treatment
- Breast cancer or prostat cancer medical history
- High energy fracture (traumatic fracture)
- No social security affiliation
- Incapacity to informed consent signed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Brabois Endocrinology
Vandœuvre-lès-Nancy, 54500
Georges WERYHA, Professor, 33 3 83 15 35 05, g.weryha@chu-nancy.fr
Anna KEARNEY-SCHWARTZ, Doctor, 33 3 83 15 33 22, a.kearney-schwartz@chu-nancy.fr
About this study
Official title: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort.
The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis
- Medical subject headings
- Osteoporosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges WERYHA, Professor, Principal investigator, CHU de Brabois Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587456
- Sponsor's protocol ID
- 2011-A00453-38
- Acronym
- ARTEOS2
- Status last verified
- Jun 2016
- First submitted
- 26 Apr 2012
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort.
- ClinicalTrials.gov ID
- NCT01587456
- Acronym / sponsor ID
- ARTEOS2 / 2011-A00453-38
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Apr 2012 (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.
The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women and men > 60 years of age with medical history of low energy fracture andradiologic osteoporosis with DXA Tscore at -2,5 DS.
Key inclusion criteria (4 listed)
- women and men > 60 years of age
- medical history of low energy fracture
- DXA Tscore -2,5 DS
- FREE AND INFORMED CONSENT SIGNED
Key exclusion criteria (6 listed)
- women and men < 60 years of age
- Corticoids treatment
- Breast cancer or prostat cancer medical history
- High energy fracture (traumatic fracture)
- No social security affiliation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Georges WERYHA, Professor principal investigator
CHU de Brabois Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Central Hospital, Nancy, France at 1 site 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 4 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Georges WERYHA, MD, PHD (33 3 83 15 35 05, g.weryha@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 16 Jun 2016.