Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

Sponsor

Odense University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00957606

Collaborator

Zealand University Hospital (Other)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Aug 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Sep 1, 2013

Outcome Measures

Primary Outcome Measures

Osteoporosis, either T-score < -2,5 or osteoporosis fracture [2½ years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, Odense University Hospital	Odense		Denmark	5000
2	Department of Urology, Roskilde Hospital	Roskilde		Denmark	4000

Sponsors and Collaborators

Odense University Hospital
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