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Completed

NCT Number: NCT02131571

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

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

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Key information

Conditions

Vertebral Fractures Back Injuries Fractures, Bone Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ramon y Cajal Hospital

Madrid, 28034, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 50 years
  • HIV infection

Exclusion criteria

  • Pregnancy
  • Receiving corticosteroids or antiresorptive therapy

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Acronym: FractaVIH

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 6, 2014
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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