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Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases

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ClinicalTrials.gov Identifier: NCT00219219
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 14, 2015
Società Italiana di Urologia (SIU)
Information provided by (Responsible Party):

Brief Summary:
The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a 15-minute infusion every 4 weeks for a maximum of 15 infusions. The protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the entire population of prostate cancer patients

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Zoledronic acid Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases
Study Start Date : September 2003
Estimated Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. occurence of skeletale related events (SREs) over time (time to first SRE,skeletal morbidity rate and proportion of patients experiencing SRE)

Secondary Outcome Measures :
  1. Bone pain
  2. Use of analgesic medication and ECOG performance status every three months
  3. Bone specific alkaline phosphatase, serum N-telopeptide and parathyroid hormone will be evaluated after one month of treatment and then every three months

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Patients aged ≥18 years
  • Written informed consent
  • Histologically-proven prostate carcinoma
  • ECOG performance status ≤ 2
  • Life expectancy > 6 months
  • Newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
  • Patients on androgen deprivation therapy (medical therapy with LHRH analogues + antiandrogens or surgical castration) or going to start it
  • Patients with partners of childbearing potential should use a barrier method of contraception throughout the study

Exclusion Criteria

  • Patients without a history of metastatic disease to the bone
  • Prior treatment with bisphosphonates
  • SREs prior to visit 2
  • Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
  • Corrected (adjusted for serum albumin - see Appendix 5 for the calculation) serum calcium concentration < 8.0 mg/dl (2.00 mmol/l)
  • Serum creatinine concentration > 265 micromol/l (3.0 mg/dl) or a calculated creatinine clearance < 30 ml/minute or serious underlying renal disease or prior renal transplantation
  • History of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
  • Other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
  • Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days
  • Known hypersensitivity to zoledronic acid or other bisphosphonates
  • History of noncompliance to medical regimens and patients who are considered potentially unreliable (for example drug or alchohol abusers) or incapable of giving informed consent as judged by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219219

Bologna, Italy
Sponsors and Collaborators
Società Italiana di Urologia (SIU)
Study Chair: Novartis Novartis

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219219     History of Changes
Other Study ID Numbers: CZOL446EIT04
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Novartis:
zoledronic acid
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents