OsteoporosisNCT02003716
DeFRA Questionnaire as an Anamnestic Form
An observational study of Osteoporosis, run by Valmontone Hospital at 1 site in Italy.
Trial summary
The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA as a "primary anamnestic from" to identify subjects at risk of osteoporosis in a population never screened before and never treated for this disease. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 767 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Mar 2014
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: general population, never screened before for osteoporosis and never subject to treatment
Who may be able to join
- age: 50 to 70 years
- no overt pathologies
- never screened before for osteoporosis
- no prior use of drugs for osteoporosis
- signed informed consent form
Who cannot join
- overt pathologies (cancer, neurodegenerative diseases, renal or hepatic insufficiency)
- use of the following drugs: cortisones, loop diuretics, antiepileptic drugs, aromatase inhibitors, dicoumarols, thyroxin in suppressive therapy, antiosteoporosis drugs)
- patients who underwent radiation therapy
- hypercalcemia or alterations of the phospho-calcic metabolism
- patients with metabolic diseases of the bone (including hyperparathyroidism or Paget disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the DeFRA Questionnaire as a "Primary Anamnestic Form" Through a Large Scale Screening of the Population
The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA as a "primary anamnestic from" to identify subjects at risk of osteoporosis in a population never screened before and never treated for this disease.
Read the detailed description
There is an increasing recognition that the management of osteoporosis requires the characterization of fracture risk to be based on absolute risk rather than single measures such as bone mineral density (BMD). However, the threshold for pharmacological intervention for osteoporosis remains controversial.
The aim of the present project is to perform a large scale study to identify subjects at risk of osteoporosis by administering the DeFRA questionnaire in a population never screened or treated before for osteoporosis.
DeFRA questionnaire will be administered before and after DEXA scanning, to further validate the questionnaire and to highlight the predictive value of this protocol as a tool to screen the general population.
- Conditions
- Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent risk of a fracture
The DeFRA questionnaire is administered within the same day with or without the DeXA measurement, to evaluate statistically significant differences in the percent risk of a fracture
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valmontone Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dell'anna Vincenzo, Valmontone Hospital
- Investigators
- Vincenzo Dell'Anna, Dr., Principal investigator, Valmontone Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003716
- Sponsor's protocol ID
- VDA-001-2012
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the DeFRA Questionnaire as a "Primary Anamnestic Form" Through a Large Scale Screening of the Population
- ClinicalTrials.gov ID
- NCT02003716
- Acronym / sponsor ID
- VDA-001-2012
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 767 participants (actual)
- Lead sponsor
- Valmontone HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Dec 2013 (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 DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA as a "primary anamnestic from" to identify subjects at risk of osteoporosis in a population never screened before and never treated for this disease.
Detailed description
There is an increasing recognition that the management of osteoporosis requires the characterization of fracture risk to be based on absolute risk rather than single measures such as bone mineral density (BMD). However, the threshold for pharmacological intervention for osteoporosis remains controversial.
The aim of the present project is to perform a large scale study to identify subjects at risk of osteoporosis by administering the DeFRA questionnaire in a population never screened or treated before for osteoporosis.
DeFRA questionnaire will be administered before and after DEXA scanning, to further validate the questionnaire and to highlight the predictive value of this protocol as a tool to screen the general population.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- general population, never screened before for osteoporosis and never subject to treatment
Key inclusion criteria (5 listed)
- age: 50 to 70 years
- no overt pathologies
- never screened before for osteoporosis
- no prior use of drugs for osteoporosis
- signed informed consent form
Key exclusion criteria (5 listed)
- overt pathologies (cancer, neurodegenerative diseases, renal or hepatic insufficiency)
- use of the following drugs: cortisones, loop diuretics, antiepileptic drugs, aromatase inhibitors, dicoumarols, thyroxin in suppressive therapy, antiosteoporosis drugs)
- patients who underwent radiation therapy
- hypercalcemia or alterations of the phospho-calcic metabolism
- patients with metabolic diseases of the bone (including hyperparathyroidism or Paget disease)
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
percent risk of a fracture
Time frame: day 1
The DeFRA questionnaire is administered within the same day with or without the DeXA measurement, to evaluate statistically significant differences in the percent risk of a fracture
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 13 Nov 2014.
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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.
Vincenzo Dell'Anna, Dr. principal investigator
Valmontone Hospital
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 Valmontone Hospital at 1 site in Italy.
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 5 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 13 Nov 2014. 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 Italy. 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?
percent risk of a fracture (time frame: day 1). 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 13 Nov 2014.