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

NCT ID: NCT05138640

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-07-31

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.

Detailed Description

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Conditions

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Fractures, Bone Patient Fall Osteoporosis Physical Activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

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

Intervention Type OTHER

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joop P.W. van den Bergh

OTHER

Sponsor Role lead

Responsible Party

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Joop P.W. van den Bergh

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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J PW van den Bergh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VieCuri Medical Centre

Locations

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VieCuri Medical Centre

Venlo, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL45707.072.13

Identifier Type: -

Identifier Source: org_study_id