Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
Phase 4
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00242554
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 150
Inclusion Criteria
- Age ≥ 18 years
- Histological confirmed diagnosis of carcinoma of the prostate
- Current or previous evidence of metastatic disease to the bone
- Receiving currently or not, hormonal therapy
- ECOG performance status of 0, 1, or 2
Exclusion Criteria
- Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
- Corrected serum calcium concentration, adjusted for serum albumin < 8.0 mg/dl (2.00 mmol/L).
- WBC<3.0x10^9, ANC < 1500/mm3, Hb < 8.0 g/dL, platelets < 75 x 10^9/L.
- Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
- Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
- Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula.
Other protocol-related inclusion / exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
- Secondary Outcome Measures
Name Time Method No secondary outcomes/objectives planned