A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00172016

Enrollment

Registered

2005-09-15

Start date

2004-01-31

Completion date

Unknown

Last updated

2012-04-30

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

Conditions

Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated

Keywords

Zoledronic acid, SRE, Prostate cancer

Brief summary

The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer

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 No maximum

Healthy volunteers

Inclusion criteria

* Written informed consent must be obtained * Age \> 18 years * Histologically confirmed diagnosis of carcinoma of the prostate * Current (or previous) objective evidence of metastatic disease to the bone * Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments * 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 (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) * WBC\<3.0x1'000'000'000, ANC \< 1500/mm3, Hgb\<8.0 g/dL, platelets \< 75 x 1'000'000'000/L. * Liver function tests \>2.5 ULN, serum creatinine \>1.5 ULN. * Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol. * Known hypersensitivity to zoledronic acid or other bisphosphonates * Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study Other protocol-defined inclusion /

Outcome results

None listed

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