Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00241111

Enrollment

148

Registered

2005-10-18

Start date

2003-09-30

Completion date

Unknown

Last updated

2017-03-06

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

Conditions

Prostate Cancer With Bone Metastasis

Keywords

Prostate, cancer, bone metastasis, zoledronic acid

Brief summary

Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.

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

* Aged ≥18 years. * Written informed consent. * With histologically-proven prostate carcinoma. * ECOG performance status ≤ 2 * Life expectancy \> 12 months * Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory) * Patients with partners of childbearing potential should use a barrier method of contraception throughout the study.

Exclusion criteria

* ECOG performans status \>3 * Prior treatment with bisphosphonates IV within the last 3 month to the study * Renal insufficiency (serum creatinine \> 265 micromol/L or \> 3.0 mg/dL) * Liver function tests \> 2.5 ULN * Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol. * History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism * Disabling or non controlled concomitant disease likely to alter the quality of life * Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient * Known hypersensitivity to zoledronic acid or other bisphosphonates Other protocol-defined inclusion /

Design outcomes

Primary

Measure	Time frame
to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment)	at 15 months & at end of study

Secondary

Measure	Time frame
to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases	V1, V2, V3, V5
to assess the safety of ZOL treatment	V1, V2, V3, V5
to assess resources consumption	V1, V2, V3, V5
to assess BM	V1 et V5

Outcome results

None listed

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