Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis

Study Overview
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Brief Summary
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It is the aim of this clinical study to evaluate the skeletal-related event rate and tolerability of zoledronic acid in patients with prostate cancer patients and bone metastases.

Official Title
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Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis

Conditions
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Prostate Cancer Patients With Bone Metastasis

Intervention / Treatment
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* Drug: Zoledronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Signed informed consent A histologically confirmed diagnosis of carcinoma of the prostate Therapy with hormonal treatments (medical or surgical castration) Patients must have objective evidence of metastatic disease to bone. Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value ECOG performance status of 0, 1 or 2 Exclusion criteria: Bone pain which requires strong narcotic therapy with centrally acting analgesic agents. More than 3 bisphosphonate applications in patients history. Previous Radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 3 months prior to Visit 2. Abnormal renal function as evidenced by A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl= [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)] Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L) Life expectancy < 6 months Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) Other protocol-defined inclusion and 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZOL446<br> | Drug: Zoledronic acid<br> <br> * Other names: ZOL446;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of skeletal complications |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first skeletal complication |  | 3 months | 
| Bone pain |  | 3 months | 
| Patients´ satisfaction with treatment |  | 3 months | 
| Bone turnover parameters |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Bone metastasis, Skeletal related event