Osteoporotic FracturesAPROPNCT03044015
Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
A study testing community based integrated strategy for secondary prevention of OF and as usual in people with Osteoporotic Fractures, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
BACKGROUND Recent evidence has been published about the effectiveness for the secondary prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services. AIM To assess the effectiveness of a primary care based intervention in the secondary prevention of OF. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Fractures
- What is being tested?
- community based integrated strategy for secondary prevention of OF and as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to Dec 2021
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major OF (distal forearm, vertebral, hip, pelvis and humerus
- Caused by a low impact mechanism
Who cannot join
- High impact mechanism of impact or secondary to other diseases (cancer, Paget disease ...)
- Patients not residing in the area of the targeted primary care practices
- Patients with an invalidating disease (dementia ...)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IDIAP Jordi Gol
Barcelona, 08007
Maria Pueyo, MD, +34 93 556 62 13, mjpueyo@gencat.cat
Bonaventura Bolibar
About this study
Official title: a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
BACKGROUND Recent evidence has been published about the effectiveness for the secondary prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.
AIM To assess the effectiveness of a primary care based intervention in the secondary prevention of OF.
Read more
METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT) level. Total study follow-up 3 years. Sample size 1800 patients.
DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up in the intervention PCT vs treatment as usual in the control branch.
ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will be analyzed through Cox proportional hazard regression model stratified by age groups.
Outcomes :
- new OF ratio in intervention vs control areas.
- maintenance of the adherence to the pharmacological and non pharmacological interventions proposed
- assessment of cost-effectivity of the intervention
- Conditions
- Osteoporotic Fractures
- Being tested
- community based integrated strategy for secondary prevention of OF, as usual
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community based integrated strategy for secondary prevention of OFBehavioural
Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care
as usualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up Receives: Behavioral: community based integrated strategy for secondary prevention of OF |
| Control | Active comparator | Intervention as usual Receives: Behavioral: as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with osteoporotic fractures
Measured: 24 months
Secondary outcomes (1)
economic cost
We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FracturesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044015
- Sponsor's protocol ID
- PDMRAL-16
- Acronym
- APROP
- Status last verified
- Feb 2020
- First submitted
- 12 Jan 2017
- Last updated
- 26 Aug 2020
- 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 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
- ClinicalTrials.gov ID
- NCT03044015
- Acronym / sponsor ID
- APROP / PDMRAL-16
- Conditions
- Osteoporotic Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Study start
- Jan 2017
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Feb 2017 (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.
BACKGROUND Recent evidence has been published about the effectiveness for the secondary prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.
AIM To assess the effectiveness of a primary care based intervention in the secondary prevention of OF.
METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT) level. Total study follow-up 3 years. Sample size 1800 patients.
DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up in the intervention PCT vs treatment as usual in the control branch.
ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will be analyzed through Cox proportional hazard regression model stratified by age groups.
Outcomes :
- new OF ratio in intervention vs control areas.
- maintenance of the adherence to the pharmacological and non pharmacological interventions proposed
- assessment of cost-effectivity of the intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: community based integrated strategy for secondary prevention of OFa defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up |
| Control | Active comparator | Behavioral: as usualIntervention as usual |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major OF (distal forearm, vertebral, hip, pelvis and humerus
- Caused by a low impact mechanism
Key exclusion criteria (3 listed)
- High impact mechanism of impact or secondary to other diseases (cancer, Paget disease ...)
- Patients not residing in the area of the targeted primary care practices
- Patients with an invalidating disease (dementia ...)
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 |
|---|---|---|
| community based integrated strategy for secondary prevention of OFEducational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care | Behavioural | Intervention |
| as usual | Behavioural | Control |
Primary outcome
Number of patients with osteoporotic fractures
Time frame: 24 months
1 secondary outcome
economic cost
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community based integrated strategy for secondary prevention of OF and as usual in people with Osteoporotic Fractures, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 3 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 26 Aug 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with osteoporotic fractures (time frame: 24 months). 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 26 Aug 2020.