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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor:
Information provided by (Responsible Party):
Itziar de Pablo López de Abechuco, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT02131571
First received: May 2, 2014
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition
Vertebral Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years: Importance of Bone Mineral Density and Bone Biomarkers

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Prevalence of vertebral fractures in HIV patients older than 50 years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Risk of vertebral alteration according to bone mineral density and serum biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the relationships of vertebral alterations with bone mineral density by dual X-ray absorptiometry

  • Vertebral alterations during follow up [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 180
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV patients older than 50 years
HIV infected patients older than 50 years in current follow up

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV infected patients older than 50 years

Criteria

Inclusion Criteria:

  • Age above 50 years
  • HIV infection

Exclusion Criteria:

  • Pregnancy
  • Receiving corticosteroids or antiresorptive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131571

Contacts
Contact: Jose L Casado, MD 34913368672 jcasado.hrc@salud.madrid.org

Locations
Spain
Ramon y Cajal Hospital Recruiting
Madrid, Spain, 28034
Contact: Jose L Casado, MD    34913368672    jcasado.hrc@gmail.com   
Principal Investigator: Jose L Casado, MD         
Principal Investigator: Monica Vazquez, MD, PhD         
Sub-Investigator: Cristina Maciá, MD         
Sub-Investigator: Sara Bañón, MD         
Sub-Investigator: Marta Rosillo, MD         
Sponsors and Collaborators
Itziar de Pablo López de Abechuco
Investigators
Principal Investigator: Jose L Casado, MD Ramon y Cajal Hospital
  More Information

No publications provided

Responsible Party: Itziar de Pablo López de Abechuco, Coordinator, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02131571     History of Changes
Other Study ID Numbers: FractaVIH 117/13, EC 117/13
Study First Received: May 2, 2014
Last Updated: May 5, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
HIV
bone
fractures
vitamin D
biomarkers

Additional relevant MeSH terms:
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on September 16, 2014