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

NCT01035177 | Terminated DMC

• 1 other identifier: P040404
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Proximal Femur Fracture

Keywords

Bone Mineral Density (BMD);; Cortical bone;; Hip fracture;; Osteoporosis;; Quantitative Computed Tomography (QCT).

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (3)

• To compare the value of BMD parameters and geometric parameters in predicting osteoporotic PFFs

  1 month

• To compare the roles for cortical bone and trabecular bone in predicting osteoporotic PFFs

  1 month

• To look for differences between cervical and trochanteric hip fractures

  1 month

Study Arms (2)

Control

Women without hip fracture, matched on age to the cases

Patient

Female patients aged 60 and older with hip fracture

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Lariboisière - APHP

Paris, 75010, France

Location

MeSH Terms

Conditions

Osteoporosis; Proximal Femoral Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Femoral Neck Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Valérie BOUSSON, PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 18, 2009
• Study Start: February 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2009
• Last Updated: December 18, 2009

Record last verified: 2008-03

Locations

FR (1)