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Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer (Osteoporosis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00957606
Recruitment Status : Unknown
Verified April 2011 by Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : August 12, 2009
Last Update Posted : April 13, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention
Study Start Date : August 2009
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: blood sampling, DXA-scan, bone scintigraphy
    Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times

Outcome Measures

Primary Outcome Measures :
  1. Osteoporosis, either T-score < -2,5 or osteoporosis fracture [ Time Frame: 2½ years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: April 2011

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

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