Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00242554

Enrollment

150

Registered

2005-10-20

Start date

2002-10-31

Completion date

Unknown

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Bone Metastases, Zoledronic acid

Brief summary

To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability

Interventions

DRUGZoledronic acid

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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 /

Design outcomes

Primary

Measure	Time frame
To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain	—

Secondary

Measure	Time frame
No secondary outcomes/objectives planned	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026