We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02045537
Recruitment Status : Recruiting
First Posted : January 27, 2014
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Study to determine the incidence of Bone Fractures in HIV infected patients in Spain

Condition or disease
HIV

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.

Study Design

Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Retrospective Study to Determine the Incidence of Bone Fractures in HIV-infected Patients in Spain
Study Start Date : June 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Fractures
Patients in follow up from 1st Jan 1997 to 1st Jan 2012 with any fracture (pathologic)


Outcome Measures

Primary Outcome Measures :
  1. number of HIV patients with bone fractures [ Time Frame: 18 years ]
    To know the incidence of bone fractures in HIV infected patients in Spain


Secondary Outcome Measures :
  1. The number of fractures associated to determine factors [ Time Frame: 18 years ]
    Determine associate factors to fractures

  2. Number of patients with fractures [ Time Frame: 18 years ]
    Determine the profile of patients with fractures


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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): 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: Juan E. Losa, MD         
H. Fundación de Alcorcón Recruiting
Alcorcón, Madrid, Spain
Principal Investigator: María Velasco, 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. Clinico San Carlos Recruiting
Madrid, Spain
Principal Investigator: Jorge Vergas, MD         
H. Universitario Clínico San Carlos Recruiting
Madrid, Spain
Principal Investigator: Vicente Estrada, MD         
H. Universitario Infanta Leonor Recruiting
Madrid, Spain
Principal Investigator: Pablo Ryan, MD         
H. Universitario La Paz Recruiting
Madrid, Spain
Principal Investigator: Ignacio Bernardino, MD         
H. Arnau de Vilanova Recruiting
Valencia, Spain
Principal Investigator: Juan Flores, MD         
H. Clinico de Valencia Recruiting
Valencia, Spain
Principal Investigator: Pepa Galindo, MD         
H. La Fe Recruiting
Valencia, Spain
Principal Investigator: José Lacruz, 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

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT02045537     History of Changes
Other Study ID Numbers: GESIDA-7312
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: February 2017

Keywords provided by Fundacion SEIMC-GESIDA:
HIV

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries