NCT00520052

Brief Summary

The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable

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

August 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
Last Updated

August 23, 2007

Status Verified

August 1, 2007

First QC Date

August 22, 2007

Last Update Submit

August 22, 2007

Conditions

Osteoporosis

Keywords

bisphosphonates, prostate cancer, bone density, osteoporosis

Outcome Measures

Primary Outcomes (1)

  • axial and peripheral bone mineral density

    over 3 years

Secondary Outcomes (1)

  • serum and urine bone turnover markers

    over 1 year

Study Arms (2)

LHRH Group

ACTIVE COMPARATOR

Patients on LHRH agonists and zoledronic acid

Drug: zoledronic acid

Bicalutamide Group

ACTIVE COMPARATOR

Patients on Bicalutamide and zoledronic acid

Drug: zoledronic acid

Interventions

zoledronic acidDRUG

5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)

Also known as: zometa
Bicalutamide GroupLHRH Group

Eligibility Criteria

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

You may qualify if:

  • patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)

You may not qualify if:

  • patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wirral Hospitals Universirt NHS Trust

Upton, Wirral, Merseyside, CH48 5PE, United Kingdom

Location

MeSH Terms

Conditions

OsteoporosisProstatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nigel J Parr, MBBS, FRCS, MD

    Wirral Hospital University NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

August 1, 2003

Study Completion

August 1, 2005

Last Updated

August 23, 2007

Record last verified: 2007-08

Locations

GB(1)