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 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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00237146

Enrollment

Registered

2005-10-12

Start date

2003-11-30

Completion date

2008-03-31

Last updated

2017-02-23

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

Conditions

Prostate Cancer

Keywords

Prostate cancer, Zoledronic acid, Bone metastasis

Brief 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.

Interventions

DRUGZoledronic acid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Venezuela

Outcome results

None listed

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