NCT00124410

Brief Summary

Osteoporosis, or thinning of the bones is a common disorder which can cause significant morbidity in terms of pain and fracture. One of the causes of osteoporosis is a low or absent testosterone level. Prostate cancer is the second most common malignancy in males with an increasing incidence. The mainstay of advanced prostate cancer treatment is hormonal manipulation (surgery or medications) in order to lower testosterone levels as testosterone stimulates cancer cells. Despite the known links both between osteoporosis, low testosterone, and prostate cancer, little data is available on how common osteoporosis is among men with advanced prostate cancer treated with hormonal manipulation. Since prostate cancer affects so many men and the indications for early hormonal manipulation are expanding, it is important to determine the prevalence of osteoporosis in these males.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2000

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

February 25, 2016

Status Verified

December 1, 2011

Enrollment Period

8.9 years

First QC Date

July 26, 2005

Last Update Submit

February 24, 2016

Conditions

Keywords

prostate cancerandrogen suppression therapy (hormone therapy)osteoporosis

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care center

You may qualify if:

  • Prostate cancer patients, on hormone therapy

You may not qualify if:

  • No prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Prostatic NeoplasmsOsteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Peter Venner, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 28, 2005

Study Start

January 1, 2000

Primary Completion

December 1, 2008

Last Updated

February 25, 2016

Record last verified: 2011-12

Locations