Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: October 9, 2005
Last updated: February 11, 2013
Last verified: February 2013
An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.
Drug: Zoledronic acid
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy.
Primary Outcome Measures:
- Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
Experimental: Zoledronic Acid
Drug: Zoledronic acid
Other Name: ZOL446
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age ≥18
- histologically confirmed adenocarcinoma of the prostate.
- Orchidectomy within the four previous weeks to enter the study.
- bone metastasis evidenced by bone scan.
- A hip DEXA study with a DS < 3.
- No hormonal therapy previous to enter the study.
- ECOG performance score of 0-2.
- Signed written informed consent.
- Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
- Any kind of hormonal therapy for prostate cancer previous to enter the study.
- Serum calcium corrected for albumin level < 8.0 mg/dl.
- WBC < 3.0x10^3, ANC < 1500/mm3, Hemoglobin < 8.0 g/dl, platelets < 75 x 10^3/l.
- Abnormal hepatic function evidenced by ALT and AST value >2.5 UNL
- Subjects with any other malignant disease that can affect the bone.
- Subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations.
- Known hypersensibility to zoledronic acid or other bisphosphonates.
- Subjects that in the investigator's opinion can not cooperate with the protocol.
Other protocol inclusion/exclusion criteria may apply.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00237146
|Novartis Investigative Site
|Caracas, Venezuela |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 9, 2005
||February 11, 2013
||Venezuela: Ministry of Health and Social Development
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Bone Density Conservation Agents
Physiological Effects of Drugs