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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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Zoledronic acid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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.

Clinical Details

Official title: 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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Locations and Contacts

Novartis Investigative Site, Caracas, Venezuela
Additional Information

Starting date: November 2003
Last updated: February 11, 2013

Page last updated: August 23, 2015

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