NCT02045537

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

24 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

7.5 years

First QC Date

January 15, 2014

Last Update Submit

February 3, 2020

Conditions

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • number of HIV patients with bone fractures

    To know the incidence of bone fractures in HIV infected patients in Spain

    18 years

Secondary Outcomes (2)

  • The number of fractures associated to determine factors

    18 years

  • Number of patients with fractures

    18 years

Study Arms (1)

Fractures

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients HIV in followed up betwen 1 Jan 1997 and 1 Jan 2012

You may qualify if:

  • HIV infection
  • Signed ICF
  • Patient that fulfill these:
  • Osteroporosis associated fracture
  • Enough information close to the moment of the fracture

You may not qualify if:

  • patients with cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

H. de Elche

Elche, Alicante, Spain

Location

H. Marina Baixa

Villajoyosa, Alicante, Spain

Location

H. Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

H. de Mataró

Mataró, Barcelona, Spain

Location

H. Sabadell

Sabadell, Barcelona, Spain

Location

Complejo Hospitalario Universitario de Ferrol

Ferrol, La Coruña, Spain

Location

H. Clinico Universitario Santiago de Compostela

Santiago de Compostela, La Coruña, Spain

Location

H. Principe de Asturias

Alcalá de Henares, Madrid, Spain

Location

H. Fundación de Alcorcón

Alcorcón, Madrid, Spain

Location

H. Severo Ochoa

Leganés, Madrid, Spain

Location

H. Clinic i Provincial

Barcelona, Spain

Location

H. Santa Creu i Sant Pau

Barcelona, Spain

Location

H. Virgen de la Luz

Cuenca, Spain

Location

H. San Pedro de Logroño

Logroño, Spain

Location

H. Clinico San Carlos

Madrid, Spain

Location

H. Universitario Clínico San Carlos

Madrid, Spain

Location

H. Universitario Infanta Leonor

Madrid, Spain

Location

H. Universitario La Paz

Madrid, Spain

Location

H. Arnau de Vilanova

Valencia, Spain

Location

H. Clinico de Valencia

Valencia, Spain

Location

H. La Fe

Valencia, Spain

Location

H. Rio Hortega

Valladolid, Spain

Location

H. Universitario Araba

Vitoria-Gasteiz, Spain

Location

H. Lozano Blesa

Zaragoza, Spain

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 27, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations