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

Sponsor
Joop P.W. van den Bergh (Other)
Overall Status
Completed
CT.gov ID
NCT05138640
Collaborator
(none)
500
1
57
8.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Not applicable. The study is designed as an observational cohort study

Study Design

Study Type:
Observational
Actual Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of Bone Strength, Physical Activity, Falls, Subsequent Fractures and Mortality in Patients Presenting With a Recent Clinical Fracture
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Subsequent falls within 3 years after a fracture [3 years]

    Number of patients sustaining a new fall during 3 years of follow-up.

  2. Mortality [3 years]

    Number of patients deceased during 3 years of follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VieCuri Medical Centre Venlo Limburg Netherlands 5912BL

Sponsors and Collaborators

  • Joop P.W. van den Bergh

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joop P.W. van den Bergh, Clinical Professor, VieCuri Medical Centre
ClinicalTrials.gov Identifier:
NCT05138640
Other Study ID Numbers:
  • NL45707.072.13
First Posted:
Dec 1, 2021
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021