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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02045537
Other study ID # GESIDA-7312
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2013
Est. completion date December 2020

Study information

Verified date January 2020
Source Fundacion SEIMC-GESIDA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study to determine the incidence of Bone Fractures in HIV infected patients in Spain


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain H. Principe de Asturias Alcalá de Henares Madrid
Spain H. Fundación de Alcorcón Alcorcón Madrid
Spain H. Germans Trias i Pujol Badalona Barcelona
Spain H. Clinic i Provincial Barcelona
Spain H. Santa Creu i Sant Pau Barcelona
Spain H. Virgen de la Luz Cuenca
Spain H. de Elche Elche Alicante
Spain Complejo Hospitalario Universitario de Ferrol Ferrol La Coruña
Spain H. Severo Ochoa Leganés Madrid
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. de Mataró Mataró Barcelona
Spain H. Sabadell Sabadell Barcelona
Spain H. Clinico Universitario Santiago de Compostela Santiago de Compostela La Coruña
Spain H. Arnau de Vilanova Valencia
Spain H. Clinico de Valencia Valencia
Spain H. La Fe Valencia
Spain H. Rio Hortega Valladolid
Spain H. Marina Baixa Villajoyosa Alicante
Spain H. Universitario Araba Vitoria
Spain H. Lozano Blesa Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Fundacion SEIMC-GESIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of HIV patients with bone fractures To know the incidence of bone fractures in HIV infected patients in Spain 18 years
Secondary The number of fractures associated to determine factors Determine associate factors to fractures 18 years
Secondary Number of patients with fractures Determine the profile of patients with fractures 18 years
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