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

April 12, 2011 updated by: Odense University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
      • Roskilde, Denmark, 4000
        • Recruiting
        • Department of Urology, Roskilde Hospital
        • Contact:
          • Claus Dahl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Osteoporosis, either T-score < -2,5 or osteoporosis fracture
Time Frame: 2½ years
2½ years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Zealand University Hospital

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 12, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCa & Osteoporosis 09
  • S-20080004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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