Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00241111
First received: October 14, 2005
Last updated: April 7, 2010
Last verified: April 2010
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Purpose
Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer With Bone Metastasis |
Drug: zoledronic acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment) [ Time Frame: at 15 months & at end of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases [ Time Frame: V1, V2, V3, V5 ] [ Designated as safety issue: Yes ]
- to assess the safety of ZOL treatment [ Time Frame: V1, V2, V3, V5 ] [ Designated as safety issue: Yes ]
- to assess resources consumption [ Time Frame: V1, V2, V3, V5 ] [ Designated as safety issue: Yes ]
- to assess BM [ Time Frame: V1 et V5 ] [ Designated as safety issue: Yes ]
| Enrollment: | 148 |
| Study Start Date: | September 2003 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Zometa |
Drug: zoledronic acid
Other Name: ZOl446
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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 / exclusion criteria may apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00241111 History of Changes |
| Other Study ID Numbers: | CZOL446EFR04 |
| Study First Received: | October 14, 2005 |
| Last Updated: | April 7, 2010 |
| Health Authority: | France: Institutional Ethical Committee |
Keywords provided by Novartis:
|
Prostate cancer bone metastasis zoledronic acid |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Genital Diseases, Male Prostatic Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013