Clinical trial · Interventional
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
NCT00242554CI-TRIAL-00026081completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
Secondary outcomes (1)
- measure
- No secondary outcomes/objectives planned
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.