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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
  Purpose

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.

Condition Intervention Phase
Prostate Cancer
Androgen Deprivation Therapy
Osteoporosis
 Procedure: blood sampling, DXA-scan, bone scintigraphy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Osteoporosis, either T-score < -2,5 or osteoporosis fracture [ Time Frame: 2½ years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: blood sampling, DXA-scan, bone scintigraphy
    Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957606

Contacts
Contact: Mads H Poulsen, MD Mads.Poulsen@ouh.regionsyddanmark.dk
Contact: Steen Walter, MD, DMSci, Professor

Locations
Denmark
Department of Urology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Mads H Poulsen, MD         Mads.Poulsen@ouh.regionsyddanmark.dk    
Contact: Steen Walter            
Department of Urology, Roskilde Hospital Recruiting
Roskilde, Denmark, 4000
Contact: Claus Dahl, MD            
Sponsors and Collaborators
Odense University Hospital
University Hospital Roskilde
University Hospital Koge
Investigators
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
  More Information

No publications provided

Responsible Party: Mads Hvid Poulsen, MD, Department of Urology, Odense University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00957606     History of Changes
Other Study ID Numbers: PCa & Osteoporosis 09, S-20080004
Study First Received: August 11, 2009
Last Updated: April 12, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Prostate cancer
androgen deprivation therapy
osteoporosis

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Osteoporosis
Bone Diseases, Metabolic
 Bone Diseases
Musculoskeletal Diseases
Genital Diseases, Male
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013