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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05138640
Enrollment
500
Registered
2021-12-01
Start date
2014-10-31
Completion date
2019-07-31
Last updated
2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures, Bone, Osteoporosis, Patient Fall, Physical Activity

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.

Interventions

OTHERNot applicable. The study is designed as an observational cohort study

Not applicable. The study is desigend as an observational cohort study

Sponsors

Joop P.W. van den Bergh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bone strength assessed with HRpQCT3 yearsDifference 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

MeasureTime frameDescription
Subsequent falls within 3 years after a fracture3 yearsNumber of patients sustaining a new fall during 3 years of follow-up.
Mortality3 yearsNumber of patients deceased during 3 years of follow-up

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026