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Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

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ClinicalTrials.gov Identifier: NCT00035997
Recruitment Status : Completed
First Posted : May 8, 2002
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:
Novartis

May 7, 2002
May 8, 2002
November 23, 2009
April 2002
January 2004   (Final data collection date for primary outcome measure)
Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
Not Provided
Complete list of historical versions of study NCT00035997 on ClinicalTrials.gov Archive Site
  • Changes in biochemical markers of bone turnover over 12 months
  • Changes in bone mineral density of the total hip at 12 months
  • Time to first skeletal-related event
  • Overall safety measured by adverse events (AEs)
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Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.

This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:

  • 18 years of age or older
  • Histologically confirmed diagnoses of prostate cancer
  • Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
  • Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments

Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: Zometa
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
200
January 2004
January 2004   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Signed informed consent
  • Age > 18 years
  • Histologically confirmed diagnosis of carcinoma of the prostate
  • Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer
  • Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either < 6 months or > 6 months
  • ECOG performance status of 0, 1, or 2

Exclusion criteria:

  • Patients who are hormone sensitive without metastatic disease to the bone
  • Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy
  • Patients who are not treated with LHRH agonist or other hormonal treatments
  • Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES
  • Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
  • Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
  • Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00035997
CZOL446EUS24
US24
Not Provided
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External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Scott L. Pescatore, PharmD. Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP