DeFRA Questionnaire as an Anamnestic Form

Use of the DeFRA Questionnaire as a Primary Anamnestic Form Through a Large Scale Screening of the Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02003716

Enrollment

767

Registered

2013-12-06

Start date

2013-09-30

Completion date

2014-03-31

Last updated

2014-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Brief 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.

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
percent risk of a fracture	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

Countries

Italy

Outcome results