DeFRA Questionnaire as an Anamnestic Form

N/ACompletedNCT02003716

Valmontone Hospital767 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

767

Conditions

Osteoporosis

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Valmontone Hospital

Valmontone, Roma, Italy

Outcomes

Primary Outcomes

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

Time frame: day 1

Data from ClinicalTrials.gov

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