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In Vivo Hip Fracture Discrimination With Quantitative Computed Tomography (QCT) (FEMFRACT)

This study has been terminated.
(Difficulties of recruitment, lack of elligible patients)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01035177
First received: December 17, 2009
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual energy X-ray absorptiometry (DXA).

Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the proximal femur analyzed using dedicated software are superior over DXA measurements of proximal femoral BMD.


Condition
Osteoporosis
Proximal Femur Fracture

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: In Vivo Discrimination of Hip Fracture With Quantitative Computed Tomography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic PFF risk, as compared to the reference standard, namely, DXA. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the value of BMD parameters and geometric parameters in predicting osteoporotic PFFs [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • To compare the roles for cortical bone and trabecular bone in predicting osteoporotic PFFs [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • To look for differences between cervical and trochanteric hip fractures [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: February 2005
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Women without hip fracture, matched on age to the cases
Patient
Female patients aged 60 and older with hip fracture

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with a history of osteoporotic hip fracture (cases) will be recruited while hospitalized in one of the study centres for immediate care of their fracture. Women without osteoporotic fractures (controls) matched on age to the cases will be recruited while receiving outpatient or inpatient care at one of the study centres. Inclusion and exclusion criteria are detailed below

Criteria

Inclusion criteria:

Selection of cases: women with hip fracture

  • woman aged 60 years and more
  • clinical suspicion of osteoporosis based on the following: trivial trauma (fall from the standing position), history of vertebral fracture or visualization of a vertebral fracture by CT
  • availability of radiographs of the proximal femur (anteroposterior view of the pelvis mandatory; anteroposterior and lateral views of the fractured hip optional)
  • signature by the patient of the informed consent document

Exclusion criteria:

  • patient under 60 years
  • current bisphosphonate, oestrogen, or SERM treatment started more than 3 months earlier; or past treatment with these medications stopped less than 6 months earlier
  • hip arthroplasty on the other side
  • fracture at the site of a bone lesion
  • psychiatric disorder that might prevent the patient from giving informed consent or from remaining completely still for about 15 minutes during the investigations
  • informed consent document not signed by the patient

Selection of controls:

The controls will be women without hip fracture matched on age to the cases.

Inclusion criteria:

  • woman aged 60 years and more
  • signature by the patient of the informed consent document

Exclusion criteria:

  • age under 60 years
  • male
  • current bisphosphonate, oestrogen, or SERM therapy started more than 3 months earlier; or past treatment with these medications stopped less than 6 months earlier
  • history of osteoporotic hip fracture.
  • psychiatric disorder that might prevent the patient from giving informed consent or from remaining completely still for about 15 minutes during the investigations
  • informed consent document not signed by the patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035177

Locations
France
Hôpital Lariboisière - APHP
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Valérie BOUSSON, PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Zakia IDIR, Department Of Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT01035177     History of Changes
Other Study ID Numbers: P040404
Study First Received: December 17, 2009
Last Updated: December 17, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Bone Mineral Density (BMD);
Cortical bone;
Hip fracture;
Osteoporosis;
Quantitative Computed Tomography (QCT).

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Hip Fractures
Osteoporosis
Wounds and Injuries
 Leg Injuries
Hip Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013