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OpenTrials
Completed

NCT Number: NCT05138640

Bone Strength and Physical Activity in Patients 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.

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Key information

Conditions

Fractures, Bone Behavior Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Patient Fall Physical Activity Wounds and Injuries

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VieCuri Medical Centre

Venlo, Limburg, 5912BL, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Mortality

    Time frame: 3 years

    Number of patients deceased during 3 years of follow-up

Sponsors and collaborators

Lead sponsor

Joop P.W. van den Bergh

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 1, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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