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

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ClinicalTrials.gov Identifier: NCT02131571
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected patients older than 50 years.

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 180 participants
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
Study Start Date : May 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of vertebral fractures in HIV patients older than 50 years [ Time Frame: 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 :
  1. Risk of vertebral alteration according to bone mineral density and serum biomarkers [ Time Frame: 2 years ]
    To determine the relationships of vertebral alterations with bone mineral density by dual X-ray absorptiometry

  2. Vertebral alterations during follow up [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Investigators
Principal Investigator: Jose L Casado, MD Ramon y Cajal Hospital
More Information

Responsible Party: 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 ( Other Identifier: Ethics Committee registry )
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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