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Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

This study is currently recruiting participants.
Verified April 2011 by Odense University Hospital
Sponsor:
Collaborators:
University Hospital Roskilde
University Hospital Koge
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00957606
First received: August 11, 2009
Last updated: April 12, 2011
Last verified: April 2011
History of Changes

August 11, 2009
April 12, 2011
August 2009
March 2013   (final data collection date for primary outcome measure)
Osteoporosis, either T-score < -2,5 or osteoporosis fracture [ Time Frame: 2½ years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00957606 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention

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.

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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Prostate Cancer
  • Androgen Deprivation Therapy
  • Osteoporosis
Procedure: blood sampling, DXA-scan, bone scintigraphy
Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • They withdraw their consent
  • Treatment for osteoporosis within the last year
  • Other malignancy
  • Other bone disease, bedbound, use of steroid
Male
Not Provided
No
Contact: Mads H Poulsen, MD Mads.Poulsen@ouh.regionsyddanmark.dk
Contact: Steen Walter, MD, DMSci, Professor
Denmark
 
NCT00957606
PCa & Osteoporosis 09, S-20080004
Yes
Mads Hvid Poulsen, MD, Department of Urology, Odense University Hospital, Denmark
Odense University Hospital
  • University Hospital Roskilde
  • University Hospital Koge
Principal Investigator: Mads H Poulsen, MD Department of Urology, Odense University Hospital, Denmark
Study Chair: Steen Walter, MD, DMSci, Professor Department of Urology, Odense University Hospital, Denmark
Study Chair: Morten MF Nielsen, MD Department of Endocrinology, Odense University Hospital, Denmark
Study Chair: Kim Brixen, MD, PhD, Professor Department of Endocrinology, Odense University Hospital, Denmark
Study Chair: Claus Dahl, MD Department of Urology, Roskilde Hospital, Denmark
Study Chair: Peter Eskildsen, MD, DMSci Department of Endocrinology, Køge Hospital, Denmark
Study Chair: Oke Gerke, PhD University of Southern Denmark
Study Chair: Bo Abrahamsen, MD, PhD, Professor Faculty of Health Sciences, University of Southern Denmark, Denmark
Odense University Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP