Osteoporosis, Management Care, FractureOPTIPOSTNCT02060747
Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.
A study testing Coordinator-based post fracture program in people with Osteoporosis, Management Care, Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears". Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Osteoporosis, Management Care, Fracture
- What is being tested?
- Coordinator-based post fracture program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2013to Dec 2016
- Phase
- Interventional
- 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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 45 years
- Fragility wrist and hip fractures
- Volunteer
Who cannot join
- Public route accident
- Emergency illness associated
- Short life expectancy
- Not volunteer
- Bedridden patient
Trial locations and contacts
1 site in 1 country.
About this study
Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears".
The most effective way to achieve this goal is through implementation of coordinator-based post fracture models of care. Exemplar models have been refered to as "Fracture Liaison Service" (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) "Osteoporosis Coordinator Program" (Canada [9,10]) or "Care Manager Programs" (USA [11,12]).
Read more
The objective of this trial is to assess efficacy of a new coordinator-based post-fracture program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after fracture thanks to an optimal recommendations practice to reduce the incidence of secondary fractures.
Men and women are included aged over 45 years with fragility wrist and hip fractures.
Evaluation criteria are based on the evidence-based assessment (stratify risk, identify secondary causes of osteoporosis, fracture evaluation), the medication adherence, others prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number of falls.
Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6 months
- Conditions
- Osteoporosis, Management Care, Fracture
- Being tested
- Coordinator-based post fracture program
- 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.
Coordinator-based post fracture programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Coordinator-based post fracture program | Experimental | The intervention arm deals with the intervention of a nurse trained in the management of osteoporosis fractures assisted by a clinical research technician who will manage the logistics and reglementary aspects of the study (patient enrollment, quality and study proceedings). Receives: Behavioral: Coordinator-based post fracture program |
| standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient with a correct management care.
This outcome is a composite outcome wich differ with each fracture type. It will be assess 6 months after patient inclusion.
An adequate management care is defined for each fracture as below.
- For wrist fracture: medical visit at J15, osteodensitometry, therapeutic decision if necessary (if not, reasons have to be precised in medical sheet).
- For hip fracture: osteodensitometry if necessary, therapeutic (chronic care) decision if necessary (if not, reasons have to be precised in medical sheet).
Measured: 6 months
Secondary outcomes (1)
Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study start1 Jul 2013
- Primary completion7 Oct 2016
- Study completionDec 2016
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 Osteoporosis, Management Care, FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060747
- Sponsor's protocol ID
- OPTIPOST
- Acronym
- OPTIPOST
- Status last verified
- Dec 2016
- First submitted
- 27 Jan 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
1. Mc Lellan AR and al. Osteoprosis Int. 2003; 1028-1034 2. Wright SA and al. Rheumatol Int 2005; 489-490 3. Clunie G and al. J Orthop Nurs 2008; 156-162 4. Boudou L and al. Osteoporos Int 2011; 2099-2016 5. Huntjzens KM ana al. Osteoporos Int 2011; 2119-2135 6. Cooper MS and al. Osteoporos Int 2012; 97-107 7. Inderjeeth CA and al. Med J Aus 2010; 149-153 8. Lih A and al. Osteoporos Int 2011; 849-858 9. Bogoch ER and al. J Bone Joint Surg Am 2006; 25-34 10. SAbder B abd al. J Bone Joint Surg Am 2008; 1197-1205 11. Dell R and al. J Bone Joint Surg Am 2008; 188-194 12. Greene D and al. J Am Acad Nurse Pract 2010; 326-329
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.
- ClinicalTrials.gov ID
- NCT02060747
- Acronym / sponsor ID
- OPTIPOST / OPTIPOST
- Conditions
- Osteoporosis, Management Care, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Feb 2014 (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.
Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears".
The most effective way to achieve this goal is through implementation of coordinator-based post fracture models of care. Exemplar models have been refered to as "Fracture Liaison Service" (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) "Osteoporosis Coordinator Program" (Canada [9,10]) or "Care Manager Programs" (USA [11,12]).
The objective of this trial is to assess efficacy of a new coordinator-based post-fracture program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after fracture thanks to an optimal recommendations practice to reduce the incidence of secondary fractures.
Men and women are included aged over 45 years with fragility wrist and hip fractures.
Evaluation criteria are based on the evidence-based assessment (stratify risk, identify secondary causes of osteoporosis, fracture evaluation), the medication adherence, others prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number of falls.
Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6 months
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinator-based post fracture program | Experimental | Behavioral: Coordinator-based post fracture programThe intervention arm deals with the intervention of a nurse trained in the management of osteoporosis fractures assisted by a clinical research technician who will manage the logistics and reglementary aspects of the study (patient enrollment, quality and study proceedings). |
| standard care | No intervention | – |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 45 years
- Fragility wrist and hip fractures
- Volunteer
Key exclusion criteria (5 listed)
- Public route accident
- Emergency illness associated
- Short life expectancy
- Not volunteer
- Bedridden patient
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 |
|---|---|---|
| Coordinator-based post fracture program | Behavioural | Coordinator-based post fracture program |
Primary outcome
Percentage of patient with a correct management care.
Time frame: 6 months
This outcome is a composite outcome wich differ with each fracture type. It will be assess 6 months after patient inclusion. An adequate management care is defined for each fracture as below. * For wrist fracture: medical visit at J15, osteodensitometry, therapeutic decision if necessary (if not, reasons have to be precised in medical sheet). * For hip fracture: osteodensitometry if necessary, therapeutic (chronic care) decision if necessary (if not, reasons have to be precised in medical sheet).
1 secondary outcome
Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).
Time frame: 6 months
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 23 Feb 2017.
- Background1. Mc Lellan AR and al. Osteoprosis Int. 2003; 1028-1034 2. Wright SA and al. Rheumatol Int 2005; 489-490 3. Clunie G and al. J Orthop Nurs 2008; 156-162 4. Boudou L and al. Osteoporos Int 2011; 2099-2016 5. Huntjzens KM ana al. Osteoporos Int 2011; 2119-2135 6. Cooper MS and al. Osteoporos Int 2012; 97-107 7. Inderjeeth CA and al. Med J Aus 2010; 149-153 8. Lih A and al. Osteoporos Int 2011; 849-858 9. Bogoch ER and al. J Bone Joint Surg Am 2006; 25-34 10. SAbder B abd al. J Bone Joint Surg Am 2008; 1197-1205 11. Dell R and al. J Bone Joint Surg Am 2008; 188-194 12. Greene D and al. J Am Acad Nurse Pract 2010; 326-329
- Individual participant dataSharing planned: Undecided
Related trials for Osteoporosis, Management Care, Fracture
Enrolling by invitationObservational study
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RecruitingObservational study
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Osteoporosis, Fracture
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinator-based post fracture program in people with Osteoporosis, Management Care, Fracture, run by Fondation Hôpital Saint-Joseph 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 5 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 23 Feb 2017. 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?
Percentage of patient with a correct management care. (time frame: 6 months). 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 NCT02060747, 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 23 Feb 2017.