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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-07-31

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.

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Detailed Description

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Conditions

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Prostate Cancer Breast Cancer Bone Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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zoledronic acid

Group Type EXPERIMENTAL

Zoledronic Acid

Intervention Type DRUG

every 4 weeks for 4 months

Interventions

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Zoledronic Acid

every 4 weeks for 4 months

Intervention Type DRUG

Other Intervention Names

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ZOL446

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No