NCT00957606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 13, 2011

Status Verified

April 1, 2011

Enrollment Period

3.6 years

First QC Date

August 11, 2009

Last Update Submit

April 12, 2011

Conditions

Prostate CancerAndrogen Deprivation TherapyOsteoporosis

Keywords

Prostate cancerandrogen deprivation therapyosteoporosis

Outcome Measures

Primary Outcomes (1)

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

    2½ years

Interventions

blood sampling, DXA-scan, bone scintigraphyPROCEDURE

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

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer
  • Initiation of androgen deprivation therapy
  • Oral and written informed consent

You may not qualify if:

  • They withdraw their consent
  • Treatment for osteoporosis within the last year
  • Other malignancy
  • Other bone disease, bedbound, use of steroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Urology, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Department of Urology, Roskilde Hospital

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsOsteoporosis

Interventions

Blood Specimen CollectionAbsorptiometry, Photon

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesRadiographyDiagnostic ImagingDensitometryPhotometryChemistry Techniques, Analytical

Study Officials

  • Mads H Poulsen, MD

    Department of Urology, Odense University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Central Study Contacts

Mads H Poulsen, MD

CONTACT

Mads.Poulsen@ouh.regionsyddanmark.dk

Steen Walter, MD, DMSci, Professor

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 12, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2013

Study Completion

September 1, 2013

Last Updated

April 13, 2011

Record last verified: 2011-04

Locations

DK(2)