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

Vertebral Fractures Clinical Trial

— FractaVIH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131571
• Other study ID #: FractaVIH 117/13
• Secondary ID: EC 117/13
• Status: Completed
• Start date: June 30, 2014
• Est. completion date: June 15, 2018

Study information

• Verified date: June 2018
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 15, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age above 50 years

• HIV infection

Exclusion Criteria:

• Pregnancy

• Receiving corticosteroids or antiresorptive therapy

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures
• Vertebral Fractures

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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