Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years

Completed

• Conditions: Vertebral Fractures

• Registration Number: NCT02131571
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary

Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected patients older than 50 years.

Detailed Description

To determine the prevalence of asymptomatic vertebral fractures in HIV patients older than 50 years, and the risk of fracture during a follow up of 2 years, according to bone mineral density at inclusion, the level of serum bone biomarkers, and the presence of secondary factors such as hypovitaminosis D or/and secondary hyperparathyroidism.

Study Timeline

• Study First Submitted: 2014-05-02
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-06
• Study Start: 2014-06-30
• Primary Completion: 2018-03-30
• Status Verified: 2018-06
• Study Completion: 2018-06-15
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Age above 50 years
• HIV infection

Exclusion Criteria

• Pregnancy
• Receiving corticosteroids or antiresorptive therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of vertebral fractures in HIV patients older than 50 years	2 years	To determine by lumbar and thoracic x ray the presence of vertebral fractures and the changes in vertebral form or size, according to Genant methods

Secondary Outcome Measures

Name	Time	Method
Vertebral alterations during follow up	2 years	To determine the emergence of vertebral alterations during 2 years of follow up according to bone mineral density, bone biomarkers (osteocalcin, beta-crosslaps), and vitamin D/parathyroid hormone (PTH) status.
Risk of vertebral alteration according to bone mineral density and serum biomarkers	2 years	To determine the relationships of vertebral alterations with bone mineral density by dual X-ray absorptiometry

Trial Locations

Locations (1)

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain