Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer

Study Overview
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Brief Summary
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Bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer. The purpose of this study is to assess the effect of zoledronic acid patients with prostate cancer or breast cancer and bone metastasis.

Official Title
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A Prospective, Single-arm Multicenter Study to Evaluate Effect of Intravenous Zoledronic Acid on Bone Metabolism Given Over 4 Months in Patients With Prostate Cancer or Breast Cancer and Bone Metastasis

Conditions
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Prostate Cancer, Breast Cancer, 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: Prostate cancer with at least one cancer-related bone lesion with or without hormonal treatment. Breast cancer with at least one cancer-related bone lesion Negative pregnancy test at screening in case of child-bearing potential and Performance status ECOG 0-2 Normal liver and kidney function Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or bone. Exclusion criteria: Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L) Current/active dental problems including infection of the teeth or jawbone dental or fixture trauma current or previous osteonecrosis of the jaw exposed bone in the mouth slow healing after dental procedures recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants) Patients with clinically symptomatic brain metastases. Severe physical or psychological concomitant diseases expected to impair compliance with the provisions of the study protocol or impair the assessment of drug of patient safety Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG History of diseases with influence on bone metabolism such as Paget´s disease and primary hyperparathyroidism and with need of treatment for osteoporosis (defined according to DVO, T-Score ≤2.5). Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month Additional 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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All

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zoledronic acid<br> | Drug: Zoledronic Acid<br>* every 4 weeks for 4 months<br>* Other names: ZOL446;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone turnover assessed by bone turnover parameters |  | every 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | every 30 days | 
| Change in prostate specific antigen |  | every 30 days | 
| Quality of Life |  | every 30 days | 
| Correlation between pain and bone turnover |  | at end of study | 
| Correlation between bone complications and bone turnover |  | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serum bone markers, bone metastasis, prostate cancer, breast cancer, quality of life, bisphosphonates