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Retrospective Study to Determine the Incidence of Bone Fractures in HIV-infected Patients in Spain (INFOHS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Fundacion SEIMC-GESIDA.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT02045537
First received: January 15, 2014
Last updated: January 23, 2014
Last verified: January 2014
  Purpose
Study to determine the incidence of Bone Fractures in HIV infected patients in Spain

Condition
HIV

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Study to Determine the Incidence of Bone Fractures in HIV-infected Patients in Spain

Resource links provided by NLM:


Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures:
  • number of HIV patients with bone fractures [ Time Frame: 18 years ] [ Designated as safety issue: No ]
    To know the incidence of bone fractures in HIV infected patients in Spain


Secondary Outcome Measures:
  • The number of fractures associated to determine factors [ Time Frame: 18 years ] [ Designated as safety issue: No ]
    Determine associate factors to fractures

  • Number of patients with fractures [ Time Frame: 18 years ] [ Designated as safety issue: No ]
    Determine the profile of patients with fractures


Estimated Enrollment: 15000
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fractures
Patients in follow up from 1st Jan 1997 to 1st Jan 2012 with any fracture (pathologic)

Detailed Description:
Study to know the incidence of bone fractures in HIV patients, determine associate factors to bone fractures, the type of patients with fractures.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients HIV in followed up betwen 1 Jan 1997 and 1 Jan 2012
Criteria

Inclusion Criteria:

  • HIV infection
  • Signed ICF
  • Patient that fulfill these:

    • Osteroporosis associated fracture
    • Enough information close to the moment of the fracture

Exclusion Criteria:

  • patients with cognitive impairment
  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: NCT02045537

Locations
Spain
H. de Elche
Elche, Alicante, Spain
H. Marina Baixa
Villajoyosa, Alicante, Spain
H. Germans Trias i Pujol
Badalona, Barcelona, Spain
H. de Mataró
Mataró, Barcelona, Spain
H. Sabadell
Sabadell, Barcelona, Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, La Coruña, Spain
H. Clinico Universitario Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
H. Principe de Asturias
Alcalá de Henares, Madrid, Spain
H. Fundación de Alcorcón
Alcorcón, Madrid, Spain
H. Severo Ochoa
Leganés, Madrid, Spain
H. Clinic i Provincial
Barcelona, Spain
H. Santa Creu i Sant Pau
Barcelona, Spain
H. Virgen de la Luz
Cuenca, Spain
H. San Pedro de Logroño
Logroño, Spain
H. Clinico San Carlos
Madrid, Spain
H. Universitario Clínico San Carlos
Madrid, Spain
H. Universitario Infanta Leonor
Madrid, Spain
H. Universitario La Paz
Madrid, Spain
H. Arnau de Vilanova
Valencia, Spain
H. Clinico de Valencia
Valencia, Spain
H. La Fe
Valencia, Spain
H. Rio Hortega
Valladolid, Spain
H. Universitario Araba
Vitoria, Spain
H. Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
  More Information

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT02045537     History of Changes
Other Study ID Numbers: GESIDA-7312 
Study First Received: January 15, 2014
Last Updated: January 23, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundacion SEIMC-GESIDA:
HIV

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on December 07, 2016