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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00035997

Collaborator

(none)

261

Enrollment

Locations

Duration (Months)

4.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Zometa	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

261 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Jan 1, 2004

Actual Study Completion Date :

Jan 1, 2004

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Norwood Clinic	Birmingham	Alabama	United States	35234
2	Alaska Clinical Research Center, LLC	Anchorage	Alaska	United States	99508
3	Advanced Urology Medical Center	Anaheim	California	United States	92801
4	Urology Associates of Central CA	Fresno	California	United States	93720
5	Center for Urological Research	La Mesa	California	United States	91942
6	Atlantic Urological Medical Group	Long Beach	California	United States	90806
7	Advanced Urology Medical Offices	Los Angeles	California	United States	90045
8	Advanced Urology Medical Office	Los Angeles	California	United States	90045
9	Boulder Medical Center	Boulder	Colorado	United States
10	Urology Associates, P.C.	Denver	Colorado	United States	80210
11	Atlantic Urological Associates	Daytona Beach	Florida	United States	32114
12	Southwest Florida Urologic Association	Fort Myers	Florida	United States
13	Diagnostic Clinic	Largo	Florida	United States	33770
14	DMI Health Care Group, Inc.	Largo	Florida	United States	33773
15	Marvin Stein, MD	Margate	Florida	United States	33063
16	Miami Cancer Institute	Miami	Florida	United States	33143
17	Advanced Research Institute	New Port Richey	Florida	United States	34652
18	Florida Foundation for Healthcare Research	Ocala	Florida	United States	34474
19	Urology Associates of Northeast Florida, PA	Orange Park	Florida	United States	32073
20	Winter Park Urology Associates	Orlando	Florida	United States	32803
21	Pinellas Urology, Inc.	St. Petersburg	Florida	United States	33710
22	Southeastern Urological Center	Tallahassee	Florida	United States	32308
23	Georgia Urology Research Institute	Atlanta	Georgia	United States	30342
24	Ball Memorial Hospital	Muncie	Indiana	United States	47303
25	Urological Associates PC	Davenport	Iowa	United States	52807
26	Drs. Werner, Murdock and Francis PA Urology Associates	Greenbelt	Maryland	United States	20770
27	Urology Associates of Middlesex County, Inc.	Marlborough	Massachusetts	United States	01752
28	Lakeside Urology, P.C.	Saint Joseph	Michigan	United States	49085
29	Millennium Medical Center	Southfield	Michigan	United States	48075
30	Kansas City Urology Care	Kansas City	Missouri	United States	64131
31	The Prostate Center of Greater St. Louis	St. Louis	Missouri	United States	63136
32	American Academy of Urology	Las Vegas	Nevada	United States	89119
33	Urological Surgical Associates	Edison	New Jersey	United States
34	UroResearch, LLC	Morristown	New Jersey	United States	07960
35	Shaukat M. Qureshi, MD	Pennsville	New Jersey	United States	08070
36	Urology Associates	Stratford	New Jersey	United States
37	Associates in Urology, LLC	West Orange	New Jersey	United States	07052
38	AccuMed Research Associates	Garden City	New York	United States	11530
39	Urological Surgeons of Long Island PC	Garden City	New York	United States	11530
40	Kingston Urological Assoc.	Kingston	New York	United States	12401
41	Cary Urology, P.A.	Cary	North Carolina	United States	27511
42	Matrix Research, LLC	Greenville	North Carolina	United States	29607
43	The Urology Group	Cincinnati	Ohio	United States	45212
44	Southwest Urology	Parma	Ohio	United States	44129
45	Roger N. Andrews, MD Inc.	Arcadia	Pennsylvania	United States	91007
46	Urologic Surgery, PC	Bala Cynwyd	Pennsylvania	United States	19004
47	James W. Thompson, MD Ltd.	Bryn Mawr	Pennsylvania	United States	09010
48	Urology Institute of Pittsburgh	Monroeville	Pennsylvania	United States	15146
49	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
50	Center for Urologic Care of Berks County	West Reading	Pennsylvania	United States	19611
51	Grand Strand Urology	Myrtle Beach	South Carolina	United States	29572
52	Urology Center of the South P.C.	Germantown	Tennessee	United States	38138
53	Murfreesboro Medical Clinic	Murfreesboro	Tennessee	United States	37130
54	Urology Associates, PA	Nashville	Tennessee	United States	37209
55	Research Across America	Carrollton	Texas	United States	75010
56	CAMC Clinical Trials	Charleston	West Virginia	United States	25304