NCT00334139
Completed
Phase 4
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
InterventionsZoledronic Acid
DrugsZoledronic Acid
Overview
- Phase
- Phase 4
- Intervention
- Zoledronic Acid
- Conditions
- Prostate Cancer
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 411
- Locations
- 1
- Primary Endpoint
- Bone turnover assessed by bone turnover parameters
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
zoledronic acid
Intervention: Zoledronic Acid
Outcomes
Primary Outcomes
Bone turnover assessed by bone turnover parameters
Time Frame: every 30 days
Secondary Outcomes
- Correlation between bone complications and bone turnover(end of study)
- Correlation between pain and bone turnover(at end of study)
- Quality of Life(every 30 days)
- Pain(every 30 days)
- Change in prostate specific antigen(every 30 days)
Study Sites (1)
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