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

Primary Purpose

Prostate Cancer, Androgen Deprivation Therapy, Osteoporosis

Status

Unknown status

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

blood sampling, DXA-scan, bone scintigraphy

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, androgen deprivation therapy, osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Urology, Odense University HospitalRecruiting
Department of Urology, Roskilde HospitalRecruiting

Outcomes

Primary Outcome Measures

Osteoporosis, either T-score < -2,5 or osteoporosis fracture

Secondary Outcome Measures

Full Information

NCT ID

NCT00957606

First Posted

August 11, 2009

Last Updated

April 12, 2011

Sponsor

Odense University Hospital

Collaborators

Zealand University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00957606

Brief Title

Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

Acronym

Osteoporosis

Official Title

Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Unknown status

Study Start Date

August 2009 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Odense University Hospital

Collaborators

Zealand University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Androgen Deprivation Therapy, Osteoporosis

Keywords

Prostate cancer, androgen deprivation therapy, osteoporosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

blood sampling, DXA-scan, bone scintigraphy

Intervention Description

Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times

Primary Outcome Measure Information:

Title

Osteoporosis, either T-score < -2,5 or osteoporosis fracture

Time Frame

2½ years

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mads H Poulsen, MD

Mads.Poulsen@ouh.regionsyddanmark.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Steen Walter, MD, DMSci, Professor

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mads H Poulsen, MD

Organizational Affiliation

Department of Urology, Odense University Hospital, Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steen Walter, MD, DMSci, Professor

Organizational Affiliation

Department of Urology, Odense University Hospital, Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Morten MF Nielsen, MD

Organizational Affiliation

Department of Endocrinology, Odense University Hospital, Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Kim Brixen, MD, PhD, Professor

Organizational Affiliation

Department of Endocrinology, Odense University Hospital, Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Claus Dahl, MD

Organizational Affiliation

Department of Urology, Roskilde Hospital, Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Peter Eskildsen, MD, DMSci

Organizational Affiliation

Department of Endocrinology, Køge Hospital, Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Oke Gerke, PhD

Organizational Affiliation

University of Southern Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bo Abrahamsen, MD, PhD, Professor

Organizational Affiliation

Faculty of Health Sciences, University of Southern Denmark, Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Urology, Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mads H Poulsen, MD

Mads.Poulsen@ouh.regionsyddanmark.dk

First Name & Middle Initial & Last Name & Degree

Steen Walter

Facility Name

Department of Urology, Roskilde Hospital

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claus Dahl, MD

12. IPD Sharing Statement

Learn more about this trial

Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

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