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 - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00035997

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Zometa	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Cancer Minerals Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months

Secondary Outcome Measures:

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)

Enrollment:	261
Study Start Date:	April 2002
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035997

Show 56 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Scott L. Pescatore, PharmD.

Novartis

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00035997 History of Changes
Other Study ID Numbers:	CZOL446EUS24, US24
Study First Received:	May 7, 2002
Last Updated:	November 20, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hormone-sensitive Prostate Cancer
Prostate Cancer
Bone Metastasis

Additional relevant MeSH terms:

Neoplasm Metastasis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male

Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Hormones
Zoledronic acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 12, 2012