Osteoporotic FracturesNCT04911946
Training of Orthopedic Residents in OP Treatment
An observational study of Osteoporotic Fractures, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Objective: To assess whether residents (R1, R2 or R3 according to the year of residency) of an orthopedic tertiary service, investigate, treat and / or refer the patient with an osteoporotic fracture to treat osteoporosis (OP) and whether this learning is improved over the years of residence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoporotic Fractures
- What is being tested?
- Questionnaire
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Jun 2021to 15 Jun 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Physicians enrolled in the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
Who may be able to join
- Physicians enrolled in the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
Who cannot join
- Abandonment of the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
- Withdrawal from the medical residency program in orthopedics and traumatology at the IOT-HC-FMUSP for a period of more than 120 days.
- Expulsion from the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
- Transfer of the medical residency program in orthopedics and traumatology from IOT-HC-FMUSP to another institution.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-010
About this study
Official title: Evaluation of the Management of Patients With Osteoporotic Fractures by Orthopedics Residents: an Observational Cross-sectional Study
Objective: To assess whether residents (R1, R2 or R3 according to the year of residency) of an orthopedic tertiary service, investigate, treat and / or refer the patient with an osteoporotic fracture to treat osteoporosis (OP) and whether this learning is improved over the years of residence.
Methods: Residents answered diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture (OF) in 4 scenarios, which were the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months. Answers were compared between years of residence.
- Conditions
- Osteoporotic Fractures
- Being tested
- Questionnaire
- Keywords
- Osteoporotic fractures, Secondary prevention, Brazil, Orthopedics, Medical professionals, Knowledge Gap, Osteoporosis treatment
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
After signing the informed consent form agreeing to participate in the study, the participants answered the questionnaire about diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture in 4 scenarios: the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| R1 | Resident of the first year of orthopedics and traumatology at IOT-HC-FMUSP. Receives: Other: Questionnaire | |
| R2 | Resident of the second year of orthopedics and traumatology at IOT-HC-FMUSP. Receives: Other: Questionnaire | |
| R3 | Resident of the third year of orthopedics and traumatology at IOT-HC-FMUSP. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary prevention of osteoporotic fracture
Number of residents investigating and treating osteoporosis in an appropriate manner
Measured: through study completion, an average of 1 month
Secondary outcomes (2)
Patient referral to secondary prevention of osteoporotic fracture
Number of residents that does not start osteoporosis treatment but refer the patient to another professional to conduct the case.
Measured: through study completion, an average of 1 month
Change the proficiency of secondary prevention with increasing graduation in the residency program
Increase the number of residents who adequately treat osteoporosis categorized by year of graduation
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start9 Jun 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcia U Rezende, PhD MD, Principal investigator, Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911946
- Sponsor's protocol ID
- 1445
- Other IDs
- 38248820.1.0000.0068
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Management of Patients With Osteoporotic Fractures by Orthopedics Residents: an Observational Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04911946
- Acronym / sponsor ID
- 1445
- Conditions
- Osteoporotic Fractures
- Keywords
- Osteoporotic fractures, Secondary prevention, Brazil, Orthopedics, Medical professionals, Knowledge Gap, Osteoporosis treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 3 Jun 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.
Objective: To assess whether residents (R1, R2 or R3 according to the year of residency) of an orthopedic tertiary service, investigate, treat and / or refer the patient with an osteoporotic fracture to treat osteoporosis (OP) and whether this learning is improved over the years of residence.
Methods: Residents answered diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture (OF) in 4 scenarios, which were the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months. Answers were compared between years of residence.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R1 | – | Other: QuestionnaireResident of the first year of orthopedics and traumatology at IOT-HC-FMUSP. |
| R2 | – | Other: QuestionnaireResident of the second year of orthopedics and traumatology at IOT-HC-FMUSP. |
| R3 | – | Other: QuestionnaireResident of the third year of orthopedics and traumatology at IOT-HC-FMUSP. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians enrolled in the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
Key inclusion criteria (1 listed)
- Physicians enrolled in the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
Key exclusion criteria (4 listed)
- Abandonment of the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
- Withdrawal from the medical residency program in orthopedics and traumatology at the IOT-HC-FMUSP for a period of more than 120 days.
- Expulsion from the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
- Transfer of the medical residency program in orthopedics and traumatology from IOT-HC-FMUSP to another institution.
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 |
|---|---|---|
| QuestionnaireAfter signing the informed consent form agreeing to participate in the study, the participants answered the questionnaire about diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture in 4 scenarios: the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months. | Other | R1, R2, R3 |
Primary outcome
Secondary prevention of osteoporotic fracture
Time frame: through study completion, an average of 1 month
Number of residents investigating and treating osteoporosis in an appropriate manner
2 secondary outcomes
Patient referral to secondary prevention of osteoporotic fracture
Time frame: through study completion, an average of 1 month
Change the proficiency of secondary prevention with increasing graduation in the residency program
Time frame: through study completion, an average of 1 month
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 25 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Marcia U Rezende, PhD MD principal investigator
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
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 Osteoporotic Fractures, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 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 25 Jun 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 Brazil. 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?
Secondary prevention of osteoporotic fracture (time frame: through study completion, an average of 1 month). 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 25 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.