Osteoporosis Among Men Treated With Androgen Deprivation... | NCT00957606

Studies
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

NCT00957606

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

Apr 13, 2011Estimated

Enrollment

100Estimated

Phase

Phase 3

Conditions

Prostate Cancer
Androgen Deprivation Therapy
Osteoporosis

Interventions

blood sampling, DXA-scan, bone scintigraphy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
S-20080004

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Mar 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Aug 11, 2009

First Submission Date that Met QC Criteria

Aug 11, 2009

First Posted Date

Aug 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2011

Last Update Posted Date

Apr 13, 2011Estimated

Name	Class
Zealand University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sampling, DXA-scan, bone scintigraphy	Procedure	Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mads H Poulsen, MD	Contact			Mads.Poulsen@ouh.regionsyddanmark.dk
Steen Walter, MD, DMSci, Professor	Contact

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Odense University Hospital	Recruiting	Odense		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D010024	Osteoporosis

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D015502	Absorptiometry, Photon

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided