NCT00536653

Brief Summary

The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
618

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 1999

Longer than P75 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

October 1, 1999

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
Last Updated

September 28, 2007

Status Verified

August 1, 2007

First QC Date

September 27, 2007

Last Update Submit

September 27, 2007

Conditions

Osteoporosis

Keywords

prostate cancerbone densityosteoporosisandrogen antagonists

Outcome Measures

Primary Outcomes (1)

  • Peripheral Forearm bone mineral density

    Over 7 years

Secondary Outcomes (1)

  • Fractures of the thoracolumbar spine

    Over 7 years

Study Arms (3)

Osteporosis Group

ACTIVE COMPARATOR

Patients with a presenting T score \< -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD

Drug: Bicalutamide and Calcium/ Vitamin D supplementation

Osteopenia Group

ACTIVE COMPARATOR

Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD

Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation

Normal Group

ACTIVE COMPARATOR

Patients with a presenting T score \> -1.0(normal BMD), treated with LHRH agonists

Drug: LHRH agonists (Goserelin acetate)

Interventions

Bicalutamide and Calcium/ Vitamin D supplementationDRUG

Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily

Osteporosis Group
LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementationDRUG

3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily

Osteopenia Group
LHRH agonists (Goserelin acetate)DRUG

3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)

Normal Group

Eligibility Criteria

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

You may qualify if:

  • Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated

You may not qualify if:

  • Previous systemic therapy for prostate cancer
  • Patients with any illness or medication that would affect bone and mineral metabolism
  • Severe hepatic or renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wirral University Hospitals NHS Trust

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

Location

MeSH Terms

Conditions

OsteoporosisProstatic Neoplasms

Interventions

bicalutamideCalciumGoserelin

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)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Nigel J Parr, MBBS, FRCS(Urol), MD

    Wirral University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 27, 2007

First Posted

September 28, 2007

Study Start

October 1, 1999

Study Completion

January 1, 2007

Last Updated

September 28, 2007

Record last verified: 2007-08

Locations

GB(1)