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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Fundacion SEIMC-GESIDA
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

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

Contacts
Contact: Herminia Esteban +34915568025 hesteban@f-sg.org
Contact: Miriam Ramírez +34915568025 mramirez@f-sg.org

Locations
Spain
H. de Elche Recruiting
Elche, Alicante, Spain
Principal Investigator: Felix Gutierrez, MD         
H. Marina Baixa Recruiting
Villajoyosa, Alicante, Spain
Principal Investigator: Concepción Amador, MD         
H. Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain
Principal Investigator: Eugenia Negredo, MD         
H. de Mataró Recruiting
Mataró, Barcelona, Spain
Principal Investigator: Pilar Barrufet, MD         
H. Sabadell Recruiting
Sabadell, Barcelona, Spain
Principal Investigator: Monserrat Sala, MD         
Complejo Hospitalario Universitario de Ferrol Recruiting
Ferrol, La Coruña, Spain
Principal Investigator: Ana Isabel Mariño, MD         
Sub-Investigator: Hortensia Alvarez, MD         
H. Clinico Universitario Santiago de Compostela Recruiting
Santiago de Compostela, La Coruña, Spain
Principal Investigator: Elena Losada, MD         
H. Principe de Asturias Recruiting
Alcalá de Henares, Madrid, Spain
Principal Investigator: José Sanz, MD         
H. Fundación de Alcorcón Recruiting
Alcorcón, Madrid, Spain
Principal Investigator: María Velasco, MD         
H. Fundación de Alcorcón Recruiting
Alcorcón, Madrid, Spain
Principal Investigator: Juan E. Losa, MD         
H. Severo Ochoa Recruiting
Leganés, Madrid, Spain
Principal Investigator: Miguel Cervero, MD         
H. Clinic i Provincial Recruiting
Barcelona, Spain
Principal Investigator: Esteban Martinez, MD         
H. Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Principal Investigator: Pere Domingo, MD         
H. Virgen de la Luz Recruiting
Cuenca, Spain
Principal Investigator: Paloma Geijo, MD         
H. San Pedro de Logroño Recruiting
Logroño, Spain
Principal Investigator: José A. Oteo, MD         
H. Universitario Clínico San Carlos Recruiting
Madrid, Spain
Principal Investigator: Vicente Estrada, MD         
H. Universitario La Paz Recruiting
Madrid, Spain
Principal Investigator: Ignacio Bernardino, MD         
H. Clinico San Carlos Recruiting
Madrid, Spain
Principal Investigator: Jorge Vergas, MD         
H. Universitario Infanta Leonor Recruiting
Madrid, Spain
Principal Investigator: Pablo Ryan, MD         
H. La Fe Recruiting
Valencia, Spain
Principal Investigator: José Lacruz, MD         
H. Clinico de Valencia Recruiting
Valencia, Spain
Principal Investigator: Pepa Galindo, MD         
H. Arnau de Vilanova Recruiting
Valencia, Spain
Principal Investigator: Juan Flores, MD         
H. Rio Hortega Recruiting
Valladolid, Spain
Principal Investigator: Pablo Bachiller, MD         
H. Universitario Araba Recruiting
Vitoria, Spain
Principal Investigator: Joseba Portu, MD         
H. Lozano Blesa Recruiting
Zaragoza, Spain
Principal Investigator: María José Crusells, MD         
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
  More Information

No publications provided

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 October 22, 2014