OsteoporosisNCT04861142
Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy
An observational study of Osteoporosis, run by University General Hospital of Heraklion at 1 site in Greece.
Trial summary
Osteoporosis and osteoporotic fractures, especially hip fractures, have a significant impact on public healthcare. Despite the fact that the patients that have suffered an osteoporotic fracture have 86% increased risk of sustaining a second osteoporotic fracture, the efforts to prevent these fractures remain… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Anti-osteoporotic medication( alendronate or denosumab)
- How many people
- 350 participants
- Where
- 1 siteGreece
- Study dates
- 23 Apr 2021to Oct 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with hip fractures after low-energy falls (fragility fractures), that are operatively treated in our department.
Who may be able to join
- Patients with hip fractures after low-energy falls(fragility fractures)
Who cannot join
- -Patients with hip fractures after high energy falls
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Heraklion
Heraklion, Crete, 71500
Theodoros Tosounidis, Assistant Professor, +30 2810395055, ttosounidis@yahoo.com
Ioannis Daskalakis
About this study
Osteoporosis and osteoporotic fractures, especially hip fractures, have a significant impact on public healthcare. Despite the fact that the patients that have suffered an osteoporotic fracture have 86% increased risk of sustaining a second osteoporotic fracture, the efforts to prevent these fractures remain inadequate. The in-hospital initiation of antiosteoporotic treatment in patients that have been admitted due to hip fracture has shown to improve treatment rates and contribute to second fracture prevention. For this purpose the Arbeitsgemeinschaft für Osteosynthesefragen (AO) Foundation has introduced an algorithm that can be used by Orthopedic surgeons for the prevention of second fracture in patients that have already suffered an osteoporotic fracture. The purpose of this thesis is to study the efficacy of this algorithm in preventing the second fracture in the greek population. The study will include patients that have been admitted in the Orthopedics department of the University Hospital of Heraklion due to hip fracture. Bone density measurement will be performed using the DXA method and antiosteoporotic treatment will be administered according to the algorithm. These patients will be included in the hip registry of the Orthopedics department and the follow-up will last for 2 years .The primary aims of the study are: a)evaluation of the adherence to the antiosteoporotic medication b)the efficacy of the adherence to the aforementioned clinical algorithm in the secondary fracture prevention in the greek population.
- Conditions
- Osteoporosis
- Being tested
- Anti-osteoporotic medication( alendronate or denosumab)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-osteoporotic medication( alendronate or denosumab)Drug
Initiation of anti-osteoporotic medication (alendronate or denosumab)
| Study group | Role | What they receive |
|---|---|---|
| Patients adherent to the anti-osteoporotic medication | Not described Receives: Drug: Anti-osteoporotic medication( alendronate or denosumab) | |
| Patients non-adherent to the anti-osteoporotic medication | Not described Receives: Drug: Anti-osteoporotic medication( alendronate or denosumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the prescribed anti-osteoporotic medication
Measured: 1 year
Secondary fracture incidence
Measured: 1 year
Secondary outcomes (1)
Morbidity and mortality of operatively treated hip fractures in our department
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start23 Apr 2021
- Primary completionMay 2024 (estimated)
- Study completionOct 2024 (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
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University General Hospital of Heraklion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Daskalakis, University General Hospital of Heraklion
- Investigators
- Ioannis Daskalakis, Orthopaedic Surgery Resident, Principal investigator, University Hospital of HeraklionTheodoros Tosounidis, Assistant Professor, Study director, University Hospital of HeraklionApostolos Karantanas, Professor, Study chair, University Hospital of HeraklionGeorgios Kontakis, Professor, Study chair, University Hospital of Heraklion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861142
- Sponsor's protocol ID
- 3224
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy
- ClinicalTrials.gov ID
- NCT04861142
- Acronym / sponsor ID
- 3224
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University General Hospital of HeraklionUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 27 Apr 2021 (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.
Osteoporosis and osteoporotic fractures, especially hip fractures, have a significant impact on public healthcare. Despite the fact that the patients that have suffered an osteoporotic fracture have 86% increased risk of sustaining a second osteoporotic fracture, the efforts to prevent these fractures remain inadequate. The in-hospital initiation of antiosteoporotic treatment in patients that have been admitted due to hip fracture has shown to improve treatment rates and contribute to second fracture prevention. For this purpose the Arbeitsgemeinschaft für Osteosynthesefragen (AO) Foundation has introduced an algorithm that can be used by Orthopedic surgeons for the prevention of second fracture in patients that have already suffered an osteoporotic fracture. The purpose of this thesis is to study the efficacy of this algorithm in preventing the second fracture in the greek population. The study will include patients that have been admitted in the Orthopedics department of the University Hospital of Heraklion due to hip fracture. Bone density measurement will be performed using the DXA method and antiosteoporotic treatment will be administered according to the algorithm. These patients will be included in the hip registry of the Orthopedics department and the follow-up will last for 2 years .The primary aims of the study are: a)evaluation of the adherence to the antiosteoporotic medication b)the efficacy of the adherence to the aforementioned clinical algorithm in the secondary fracture prevention in the greek population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients adherent to the anti-osteoporotic medication | – | Drug: Anti-osteoporotic medication( alendronate or denosumab) |
| Patients non-adherent to the anti-osteoporotic medication | – | Drug: Anti-osteoporotic medication( alendronate or denosumab) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hip fractures after low-energy falls (fragility fractures), that are operatively treated in our department.
Key inclusion criteria (1 listed)
- Patients with hip fractures after low-energy falls(fragility fractures)
Key exclusion criteria (1 listed)
- -Patients with hip fractures after high energy falls
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 |
|---|---|---|
| Anti-osteoporotic medication( alendronate or denosumab)Initiation of anti-osteoporotic medication (alendronate or denosumab) | Drug | Patients adherent to the anti-osteoporotic medication, Patients non-adherent to the anti-osteoporotic medication |
Primary outcome
Adherence to the prescribed anti-osteoporotic medication
Time frame: 1 year
Secondary fracture incidence
Time frame: 1 year
1 secondary outcome
Morbidity and mortality of operatively treated hip fractures in our department
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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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.
Ioannis Daskalakis, Orthopaedic Surgery Resident principal investigator
University Hospital of Heraklion
Theodoros Tosounidis, Assistant Professor study director
University Hospital of Heraklion
Apostolos Karantanas, Professor study chair
University Hospital of Heraklion
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 University General Hospital of Heraklion at 1 site in Greece.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. 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 Greece. 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 Theodoros Tosounidis, Assistant Professor (+30 2810395055, ttosounidis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the prescribed anti-osteoporotic medication (time frame: 1 year). The study lists 2 primary outcomes in all. 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 27 Apr 2021.