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Completed

NCT Number: NCT02003716

DeFRA Questionnaire as an Anamnestic Form

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.

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Key information

Age range

50 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Valmontone Hospital

Valmontone, Roma, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Valmontone Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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