Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture

Study Overview
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Brief Summary
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The risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. The risk for a subsequent fracture is not dependent of BMD as measured by conventional DXA. In recent studies, it has been shown that HRpQCT measurements provide information about bone structure, bone quality and bone strength in addition to BMD measurements. Diagnostic strategies should be focussed on bone quality and bone strength and fall prediction in the patients at high risk for falls, subsequent fracture and mortality such as patients with a recent fracture. Therefore, the investigators conduct a prospective observational study in 500 patients aged 50 years and older who present with a clinical fracture for evaluation of bone strength, physical activity, falls, subsequent fractures and mortality during a follow-up period of 3 years.

Official Title
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Prospective Evaluation of Bone Strength, Physical Activity, Falls, Subsequent Fractures and Mortality in Patients Presenting With a Recent Clinical Fracture

Conditions
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Fractures, Bone, Patient Fall, Osteoporosis, Physical Activity

Intervention / Treatment
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* Other: Not applicable. The study is designed as an observational cohort study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 50 years and older with a recent fracture that is being evaluated at the FLS at VieCuri MC. Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical study procedures Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion. Exclusion Criteria: Patients with malignancy metastatic to the bone. Patients with osteomyelitis. Patients with fractures due to failure of a prosthesis. Patients, who as judged by the Principal Investigator, are mentally incompetent. Patients who are compos mentis and understand the patient information, will not be considered mentally incompetent

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Not applicable. The study is designed as an observational cohort study|Not applicable. The study is desigend as an observational cohort study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone strength assessed with HRpQCT | Difference in bone strength, estimated by micro-finite element analyses, will be compared between patients with and without a subsequent fracture within 3 years of follow-up. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsequent falls within 3 years after a fracture | Number of patients sustaining a new fall during 3 years of follow-up. | 3 years | 
| Mortality | Number of patients deceased during 3 years of follow-up | 3 years |