The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis

Novartis Pharmaceuticals7 sites in 1 country28 target enrollmentJune 2004

ConditionsProstate Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Novartis Pharmaceuticals
Enrollment: 28
Locations: 7
Primary Endpoint: Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being conducted to evaluate the effect of an investigational drug on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT).

In order to participate, male patients 18 years and older must be veterans from participating Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have established osteoporosis.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

March 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Signed informed consent
•Age \> 18 years
•Histologically confirmed diagnosis of carcinoma of the prostate
•Stage M0: Patients just starting ADT must be stage M0 \[PSA \<10 (then bone scan not needed) or negative bone scan (regardless of PSA)\]. Patients already on ADT must have been M0 at the initiation of ADT and have maintained a stable, low PSA (\< 2.0) on continuous ADT since that time.
•Patients initiating or receiving ADT with a LHRH agonist (with or without an antiandrogen) and with the intended duration of ADT of at least 12 months from the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible. For patients already on ADT, the therapy must be continuous, and if there is more than one missed or delayed dose (\> 1 mo delay) in any one year period, the patient is not eligible.
•Patient with a baseline BMD T-score \<-2.0 in the lumbar spine (L2-L4) and/or the total hip are eligible
•Life expectancy of at least 12 months
•Zubrod performance status of 0, 1, or 2
•Exclusion Criteria
•Patients who received any bisphosphonate therapy in the past 6 months

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.

Time Frame: 12 months

Secondary Outcomes

Percent change in bone mineral density of the total hip (including femoral neck, trochanteric region, and Ward's triangle) following one year of therapy.(12 months)