NCT00181584

Brief Summary

The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

2.4 years

First QC Date

September 9, 2005

Last Update Submit

July 9, 2013

Conditions

Bone LossProstate Cancer

Keywords

Androgen deprivation therapybone lossprostate cancerZoledronic AcidZometa

Outcome Measures

Primary Outcomes (1)

  • To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.

    3 years

Secondary Outcomes (2)

  • To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo

    3 years

  • to assess the safety and tolerability of zoledronic acid.

    3 years

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Drug: Zoledronic acid

Group 2

PLACEBO COMPARATOR
Other: Placebo

Interventions

Zoledronic acidDRUG

Given intravenously once.

Also known as: Zometa
Group 1
PlaceboOTHER

Given intravenously once.

Group 2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adenocarcinoma of the prostate
  • Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months
  • Corrected serum calcium \> 8.4mg/dl and \< 10.6mg/dl
  • Serum creatinine \< 2.0mg/dl

You may not qualify if:

  • History of bone metastases by bone scan
  • Treatment with bisphosphonate within one year
  • History of metabolic disease
  • Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicProstatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone 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

  • Matthew Smith, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

September 1, 2003

Primary Completion

February 1, 2006

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(2)