OsteoporosisSIOUXNCT02892188
Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up
An observational study of Osteoporosis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Feb 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: Patient having osteoporosis enrolled into the programm of Therapeutical Educational for patient
Who may be able to join
- older than 18 years old
- having an osteoporosis treatment
- following a Therapeutical Education for Patient
Who cannot join
- opposition for anonymised data gathering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Follow-up of Osteoporotic Patients by a Physician-pharmacist Collaboration
The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration.
Read the detailed description
Treatments allow decreasing the personal fracture risk from 48% to 85% provided that the treatment period is continued at least 3 to 5 years and that hygienic and dietary measures are applied: optimization of the dietary calcium intakes (much more efficient and less dangerous than the medicinal intakes), preservation of a physical activity, fall prevention. The ability of bisphosphonate for decreasing significantly the number of fractures was proved, but the lack of lasting adhesion (persistence) and of flanking measures leads to believe their efficiency may be enhanced: the hip-fracture rate decreases from 2.1% for the non-adherents to 1,3% for the patients with observance, which represents a one-half reduction.
The cost of surgery for a femoral neck fracture is estimated at 8500 euros. So the prevention of only one femoral neck fracture entails a huge economy.
However, 50% of women stop their treatment before a year and the implementation of hygienic and dietary measures leads to a lifestyle change, and faces long time ingrained habits. Only 42% of patients continue their treatment after two years, and only 16% after three years.
- Conditions
- Osteoporosis
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Respect of treatment and of hygienic dietary measures by patients with a self-questionnaire per medical check
This assessment will be made at the end of the follow-up, after three years, but an intermediary assessment about those same criteria is planned at one and two years of the follow-up.
Measured: year 3
Secondary outcomes (2)
Qualitative evaluation of the professional adhesion for the follow-up process once a year during the annual meeting
This assessment will be made at the end of the follow-up, after three years, but an intermediary assessment about those same criteria is planned at one and two years of the follow-up.
Measured: year 3
Quantitative evaluation of it by the return rate of questionnaires
This assessment will be made at the end of the follow-up, after three years, but an intermediary assessment about those same criteria is planned at one and two years of the follow-up.
Measured: year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2019
- Study completionFeb 2019
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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier POIVRET, MD, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892188
- Sponsor's protocol ID
- 2013-01Obs-CHRMT
- Acronym
- SIOUX
- Status last verified
- Dec 2019
- First submitted
- 26 Aug 2016
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Follow-up of Osteoporotic Patients by a Physician-pharmacist Collaboration
- ClinicalTrials.gov ID
- NCT02892188
- Acronym / sponsor ID
- SIOUX / 2013-01Obs-CHRMT
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 8 Sep 2016 (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 purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration.
Detailed description
Treatments allow decreasing the personal fracture risk from 48% to 85% provided that the treatment period is continued at least 3 to 5 years and that hygienic and dietary measures are applied: optimization of the dietary calcium intakes (much more efficient and less dangerous than the medicinal intakes), preservation of a physical activity, fall prevention. The ability of bisphosphonate for decreasing significantly the number of fractures was proved, but the lack of lasting adhesion (persistence) and of flanking measures leads to believe their efficiency may be enhanced: the hip-fracture rate decreases from 2.1% for the non-adherents to 1,3% for the patients with observance, which represents a one-half reduction.
The cost of surgery for a femoral neck fracture is estimated at 8500 euros. So the prevention of only one femoral neck fracture entails a huge economy.
However, 50% of women stop their treatment before a year and the implementation of hygienic and dietary measures leads to a lifestyle change, and faces long time ingrained habits. Only 42% of patients continue their treatment after two years, and only 16% after three years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient having osteoporosis enrolled into the programm of Therapeutical Educational for patient
Key inclusion criteria (3 listed)
- older than 18 years old
- having an osteoporosis treatment
- following a Therapeutical Education for Patient
Key exclusion criteria (1 listed)
- opposition for anonymised data gathering
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
Respect of treatment and of hygienic dietary measures by patients with a self-questionnaire per medical check
Time frame: year 3
This assessment will be made at the end of the follow-up, after three years, but an intermediary assessment about those same criteria is planned at one and two years of the follow-up.
2 secondary outcomes
Qualitative evaluation of the professional adhesion for the follow-up process once a year during the annual meeting
Time frame: year 3
Quantitative evaluation of it by the return rate of questionnaires
Time frame: year 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- 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.
Didier POIVRET, MD principal investigator
CHR Metz-Thionville
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 Centre Hospitalier Régional Metz-Thionville 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Respect of treatment and of hygienic dietary measures by patients with a self-questionnaire per medical check (time frame: year 3). 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 2 Jan 2020.