DeFRA Questionnaire as an Anamnestic Form

NCT ID: NCT02003716

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

767 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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

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Osteoporosis

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age: 50 to 70 years
* no overt pathologies
* never screened before for osteoporosis
* no prior use of drugs for osteoporosis
* signed informed consent form

Exclusion Criteria

* 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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Valmontone Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dell'anna Vincenzo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincenzo Dell'Anna, Dr.

Role: PRINCIPAL_INVESTIGATOR

Valmontone Hospital

Locations

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Valmontone Hospital

Valmontone, Roma, Italy

Site Status

Countries

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Italy

Other Identifiers

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VDA-001-2012

Identifier Type: -

Identifier Source: org_study_id