Maintaining Bone Strength in Men With Prostate Cancer

Phase 3TerminatedNCT00391950

Novartis300 enrolled

Overview

The purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. Both patient and doctor will know which treatment a patient is receiving. After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. All participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Prostate Cancer

Interventions

Zoledronic acidDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: Histologically confirmed diagnosis of carcinoma of the prostate * No distant metastases * Patients must be candidates for androgen deprivation therapy (ADT) * Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible Exclusion criteria: Patients with normal BMD at trial entry * Patients who received any prior bisphosphonate therapy in the past 12 months * Treatment with anti-androgen mono- or combination therapy * Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES * Patients who have received prior treatment with systemic corticosteroids within the past 12 months * Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months * Patients with any prior treatment for osteoporosis Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Unnamed facility

Derby, United Kingdom

Outcomes

Primary Outcomes

Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan

Secondary Outcomes

To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:

The percent change in BMD of the total hip following one year of therapy and the forearm following one year of therapy. This will be carried out at a limited number of centres.

Quality of life following one year of therapy.

Various biochemical markers of bone resorption (N-telopeptide, NTX, C-telopeptide, CTX, TRACP, PINP) and bone formation (bone alkaline phosphatase, BAP) during one year of therapy. This will be carried out at a limited number of centres.

Percentage of and rate of vertebral and hip fractures.

Safety and tolerability

Data from ClinicalTrials.gov

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