NCT00226954

Brief Summary

Primary: To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently. Secondary Objectives: To describe the safety and tolerability at this dose and schedule

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

4.7 years

First QC Date

September 13, 2005

Last Update Submit

March 16, 2020

Conditions

Urologic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.

Secondary Outcomes (1)

  • To describe the safety and tolerability at this dose and schedule

Study Arms (1)

Zoledronic Acid with Intermittent Hormonal Therapy

EXPERIMENTAL
Drug: zoledronic acid

Interventions

zoledronic acidDRUG
Zoledronic Acid with Intermittent Hormonal Therapy

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Urologic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dr. Sandy Srinivas

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 27, 2005

Study Start

March 1, 2003

Primary Completion

November 1, 2007

Study Completion

February 1, 2009

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

US(1)