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

November 16, 2021 updated by: Joop P.W. van den Bergh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- Limburg
  - Venlo, Limburg, Netherlands, 5912BL
    - VieCuri Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a recent fracture evaluated at the FLS at VieCuri MC Venlo

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone strength assessed with HRpQCT Time Frame: 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.	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joop P.W. van den Bergh

Investigators

Principal Investigator: J PW van den Bergh, MD, PhD, VieCuri Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)