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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01284608
Other study ID # NIS-OES-DUM-2010/1
Secondary ID
Status Completed
Phase N/A
First received January 26, 2011
Last updated December 21, 2012
Start date March 2011
Est. completion date December 2012

Study information

Verified date December 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
Study type Observational

Clinical Trial Summary

This is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using FRAX model in patients with prostate cancer. The patients will be following for 12 months


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Prostate cancer patient requiring androgen-ablation treatment: LHRH analogs, surgical castration, antiandrogen treatment

- Provision of informed consent prior to conducting any study-related procedure

Exclusion Criteria:

- Patient involved in a Clinical Trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Research Site Albacete
Spain Research Site Alcala de Henares Madrid
Spain Research Site Antequera Malaga
Spain Research Site Aranda de Duero Burgos
Spain Research Site Baracaldo Vizcaya
Spain Research Site Barcelona
Spain Research Site Bilbao Vizcaya
Spain Research Site Calatayud Zaragoza
Spain Research Site Cordoba
Spain Research Site Coslada Madrid
Spain Research Site El Ejido Almeria
Spain Research Site El Hospitalet de Llobregat Barcelona
Spain Research Site Ferrol Coru?a
Spain Research Site Galdakao Vizcaya
Spain Research Site Granada
Spain Research Site Guadalajara
Spain Research Site Huercal Overa Almeria
Spain Research Site Jaen
Spain Research Site Logrono La Rioja
Spain Research Site Madrid
Spain Research Site Majadahonda Madrid
Spain Research Site Merida Badajoz
Spain Research Site Miranda de Ebro Burgos
Spain Research Site Monforte (casco Urbano) Lugo
Spain Research Site Osuna Sevilla
Spain Research Site Palma de Mallorca Illes Balears
Spain Research Site Reus Tarragona
Spain Research Site Sabadell Barcelona
Spain Research Site San Sebastian Guipuzcoa
Spain Research Site San Sebastian de Los Reyes Madrid
Spain Research Site Toledo
Spain Research Site Vigo Pontevedra
Spain Research Site Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolic syndrome 3 months No
Primary Metabolic syndrome 6 months No
Primary Metabolic syndrome 12 months No
Primary Diabetes 3 months No
Primary Diabetes 6 months No
Primary Diabetes 12 months No
Secondary Fracture Risk Assessment Tool (FRAx) assessment 0 and 12 months No
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