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DeFRA Questionnaire as an Anamnestic Form

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ClinicalTrials.gov Identifier: NCT02003716
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Dell'anna Vincenzo, Valmontone Hospital

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.

Condition or disease
Osteoporosis

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.


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Study Type : Observational
Actual Enrollment : 767 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Use of the DeFRA Questionnaire as a "Primary Anamnestic Form" Through a Large Scale Screening of the Population
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort
No treatment



Primary Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
general population, never screened before for osteoporosis and never subject to treatment
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003716


Locations
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Italy
Valmontone Hospital
Valmontone, Roma, Italy
Sponsors and Collaborators
Valmontone Hospital
Investigators
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Principal Investigator: Vincenzo Dell'Anna, Dr. Valmontone Hospital

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Responsible Party: Dell'anna Vincenzo, Principal Investigator, Valmontone Hospital
ClinicalTrials.gov Identifier: NCT02003716     History of Changes
Other Study ID Numbers: VDA-001-2012
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases