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

NCT05138640 | Completed

• 1 other identifier: NL45707.072.13
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone; Patient Fall; Osteoporosis; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subsequent falls within 3 years after a fracture

  3 years

• Mortality

  3 years

Interventions

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

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

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joop P.W. van den Bergh: lead

Study Sites (1)

VieCuri Medical Centre

Venlo, Limburg, 5912BL, Netherlands

Location

MeSH Terms

Conditions

Fractures, Bone; Osteoporosis; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• J PW van den Bergh, MD, PhD

  VieCuri Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: December 1, 2021
• Study Start: October 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

NL (1)