DeFRA Questionnaire as an Anamnestic Form

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003716
• Other study ID #: VDA-001-2012
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: November 11, 2014
• Start date: September 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2014
• Source: Valmontone Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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)

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
Italy	Valmontone Hospital	Valmontone	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Valmontone Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 1	No