Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

Phase 3

• Conditions: Prostate Cancer; Androgen Deprivation Therapy; Osteoporosis

• Registration Number: NCT00957606
• Lead Sponsor: Odense University Hospital

Brief Summary

The purpose of this study is

* to determine the rate of osteoporosis among patients with advanced prostate cancer.

* to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis.

Detailed Description

Patients with advanced prostate cancer are included at the initiating of androgen deprivation therapy.

The patients are followed for 2 years after inclusion with blood sampling, DXA-scan, questionnaire, bone scintigraphy.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-12
• Last Update Posted: 2011-04-13
• Primary Completion: 2013-03
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Prostate cancer
• Initiation of androgen deprivation therapy
• Oral and written informed consent

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Exclusion Criteria

• They withdraw their consent
• Treatment for osteoporosis within the last year
• Other malignancy
• Other bone disease, bedbound, use of steroid

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Osteoporosis, either T-score < -2,5 or osteoporosis fracture	2½ years

Trial Locations

Locations (2)

Department of Urology, Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Department of Urology, Odense University Hospital; 🇩🇰 Odense, Denmark