Maintaining Bone Strength in Men With Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Randomized, Multicentre Study to Evaluate the Efficacy of Two Zoledronic Acid Schedules on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Zoledronic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic acid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Cancer treatment induced bone loss (CTIBL), Androgen deprivation therapy (ADT)