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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138640
• Other study ID #: NL45707.072.13
• Status: Completed
• Start date: October 2014
• Est. completion date: July 2019

Study information

• Verified date: November 2021
• Source: VieCuri Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Patient Fall
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
Netherlands	VieCuri Medical Centre	Venlo	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Joop P.W. van den Bergh

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subsequent falls within 3 years after a fracture	Number of patients sustaining a new fall during 3 years of follow-up.	3 years
Secondary	Mortality	Number of patients deceased during 3 years of follow-up	3 years