Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo. Zometa is administered intravenously over a 15 minute prior once in this one year study. All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study. All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.

Official Title
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Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Conditions
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Bone Loss, Prostate Cancer

Intervention / Treatment
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* Drug: Zoledronic acid
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Drug: Zoledronic acid<br>* Given intravenously once.<br>* Other names: Zometa;|
| Placebo Comparator: Group 2<br> | Other: Placebo<br>* Given intravenously once.<br>|

What is the study measuring?
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Primary Outcome Measures

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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone loss, Androgen deprivation therapy, prostate cancer, Zoledronic Acid, Zometa