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

Completed

• Conditions: Patient Fall; Fractures, Bone; Osteoporosis; Physical Activity

• Registration Number: NCT05138640
• Lead Sponsor: Joop P.W. van den Bergh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-26
• Study Start: 2014-10
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone strength assessed with HRpQCT	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Subsequent falls within 3 years after a fracture	3 years	Number of patients sustaining a new fall during 3 years of follow-up.
Mortality	3 years	Number of patients deceased during 3 years of follow-up

Trial Locations

Locations (1)

VieCuri Medical Centre; 🇳🇱 Venlo, Limburg, Netherlands