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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00334139

Collaborator

(none)

411

Enrollment

Location

Arm

Actual Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Breast Cancer Bone Metastasis	Drug: Zoledronic Acid	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

411 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: zoledronic acid	Drug: Zoledronic Acid every 4 weeks for 4 months Other Names: ZOL446

Arm

Intervention/Treatment

Experimental: zoledronic acid

Drug: Zoledronic Acid

every 4 weeks for 4 months

Other Names:

ZOL446

Outcome Measures

Primary Outcome Measures

Bone turnover assessed by bone turnover parameters [every 30 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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