Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

NCT ID: NCT00957606

Last Updated: 2011-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Androgen Deprivation Therapy Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood sampling, DXA-scan, bone scintigraphy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zealand University Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Urology, Odense University Hospital, Denmark

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mads H Poulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Odense University Hospital, Denmark

Steen Walter, MD, DMSci, Professor

Role: STUDY_CHAIR

Department of Urology, Odense University Hospital, Denmark

Morten MF Nielsen, MD

Role: STUDY_CHAIR

Department of Endocrinology, Odense University Hospital, Denmark

Kim Brixen, MD, PhD, Professor

Role: STUDY_CHAIR

Department of Endocrinology, Odense University Hospital, Denmark

Claus Dahl, MD

Role: STUDY_CHAIR

Department of Urology, Roskilde Hospital, Denmark

Peter Eskildsen, MD, DMSci

Role: STUDY_CHAIR

Department of Endocrinology, Køge Hospital, Denmark

Oke Gerke, PhD

Role: STUDY_CHAIR

University of Southern Denmark

Bo Abrahamsen, MD, PhD, Professor

Role: STUDY_CHAIR

Faculty of Health Sciences, University of Southern Denmark, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Urology, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Department of Urology, Roskilde Hospital

Roskilde, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mads H Poulsen, MD

Role: CONTACT

Steen Walter, MD, DMSci, Professor

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mads H Poulsen, MD

Role: primary

Steen Walter

Role: backup

Claus Dahl, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S-20080004

Identifier Type: -

Identifier Source: secondary_id

PCa & Osteoporosis 09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

OSTPRE-Fracture Prevention Study
NCT00592917 COMPLETED PHASE4
Osteoporosis School
NCT00224991 COMPLETED NA