OsteoporosisNCT03994094
Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures
An observational study of Osteoporosis and Osteoporotic Fractures, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Osteoporotic Fractures
- What is being tested?
- Telephone interview
- How many people
- 147 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2019to 1 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who were enrolled in the cohort of the osteoporosis clinic of our hospital between january 2012 and December 2015 following an osteoporotic fracture.
Who may be able to join
- Patients who had an osteoporotic fracture followed by the osteoporosis clinic since between January 2012 and December 2015
- Acceptation of the telephone interview
Who cannot join
- Age < 18 years
- No social security coverage
Trial locations and contacts
1 site in 1 country.
About this study
A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis.
The effectiveness specialized osteoporosis clinics is the subject of numerous publications.
It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.
- Conditions
- Osteoporosis, Osteoporotic Fractures
- Being tested
- Telephone interview
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone interviewOther
Structured, directive, telephone interview, in order to collect the outcome measures in addition to the patients electronic health record.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fractures since the enrollment in the clinic
Number of incident fractures suffered by the patient since their enrollment in the osteoporosis clinic.
Measured: From the enrollment of patients between january 2012 and december 2015 to the interview date
Secondary outcomes (2)
Evolution of bone mineral density since the enrollment in the clinic
Evolution of the bone mineral density since their enrollment in the osteoporosis clinic
Measured: From the enrollment of patients between january 2012 and december 2015 to the interview date
Satisfaction with the osteoporosis clinic
Level of satisfaction measured with a four level Lickert scale ( Very satisfied ? Satisfied? Unsatisfied? Dissatisfied?)
Measured: From the enrollment of patients between january 2012 and december 2015 to the interview date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start12 Jun 2019
- Primary completion20 Jul 2019
- Study completion1 Sep 2019 (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.
- 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
- Retrospective
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte Haettich, MD, Principal investigator, Centre Hospitalier du Mans, Rheumatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994094
- Sponsor's protocol ID
- CHM-2019-S7/01
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures
- ClinicalTrials.gov ID
- NCT03994094
- Acronym / sponsor ID
- CHM-2019-S7/01
- Conditions
- Osteoporosis, Osteoporotic Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 21 Jun 2019 (actual)
- 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.
A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis.
The effectiveness specialized osteoporosis clinics is the subject of numerous publications.
It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who were enrolled in the cohort of the osteoporosis clinic of our hospital between january 2012 and December 2015 following an osteoporotic fracture.
Key inclusion criteria (2 listed)
- Patients who had an osteoporotic fracture followed by the osteoporosis clinic since between January 2012 and December 2015
- Acceptation of the telephone interview
Key exclusion criteria (2 listed)
- Age < 18 years
- No social security coverage
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 |
|---|---|---|
| Telephone interviewStructured, directive, telephone interview, in order to collect the outcome measures in addition to the patients electronic health record. | Other | – |
Primary outcome
Number of fractures since the enrollment in the clinic
Time frame: From the enrollment of patients between january 2012 and december 2015 to the interview date
Number of incident fractures suffered by the patient since their enrollment in the osteoporosis clinic.
2 secondary outcomes
Evolution of bone mineral density since the enrollment in the clinic
Time frame: From the enrollment of patients between january 2012 and december 2015 to the interview date
Satisfaction with the osteoporosis clinic
Time frame: From the enrollment of patients between january 2012 and december 2015 to the interview date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Bénédicte Haettich, MD principal investigator
Centre Hospitalier du Mans, Rheumatology Department
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 and Osteoporotic Fractures, run by Centre Hospitalier le Mans 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 2 inclusion and 2 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 21 Aug 2019. 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?
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?
Number of fractures since the enrollment in the clinic (time frame: From the enrollment of patients between january 2012 and december 2015 to the interview date). It is what the study was designed to measure, not a finding.
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 21 Aug 2019.