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

Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years: Importance of Bone Mineral Density and Bone Biomarkers

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

Study Overview

• Status: Completed
• Conditions: Vertebral Fractures

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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Ramón y Cajal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV infected patients older than 50 years

Description

Inclusion Criteria:

• Age above 50 years
• HIV infection

Exclusion Criteria:

• Pregnancy
• Receiving corticosteroids or antiresorptive therapy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HIV patients older than 50 years; HIV infected patients older than 50 years in current follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of vertebral fractures in HIV patients older than 50 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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of vertebral alteration according to bone mineral density and serum biomarkers	To determine the relationships of vertebral alterations with bone mineral density by dual X-ray absorptiometry	2 years
Vertebral alterations during follow up	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.	2 years

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Investigators: Principal Investigator: Jose L Casado, MD, Ramón y Cajal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2014
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: May 2, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: HIV; biomarkers; bone; fractures; vitamin D
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID Numbers: FractaVIH 117/13; EC 117/13 (Other Identifier: Ethics Committee registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No