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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05138640
Other study ID # NL45707.072.13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date July 2019

Study information

Verified date November 2021
Source VieCuri Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility 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


Intervention

Other:
Not applicable. The study is designed as an observational cohort study
Not applicable. The study is desigend as an observational cohort study

Locations

Country Name City State
Netherlands VieCuri Medical Centre Venlo Limburg

Sponsors (1)

Lead Sponsor Collaborator
Joop P.W. van den Bergh

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Subsequent falls within 3 years after a fracture Number of patients sustaining a new fall during 3 years of follow-up. 3 years
Secondary Mortality Number of patients deceased during 3 years of follow-up 3 years
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