The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00063609

Collaborator

(none)

200

Enrollment

Locations

Duration (Months)

4.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. In addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate.

Patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. Also patients who are receiving treatment for osteoporosis are not eligible to participate.

Inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: zoledronic acid	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy

Study Start Date :

Apr 1, 2003

Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Percent change in bone mineral density of the lumbar spine (L2-L4) at one year. []

Secondary Outcome Measures

Percent changes in bone mineral density of the total hip []
biochemical markers of bone turnover at one year []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Histologically confirmed diagnosis of carcinoma of the prostate
No distant metastases (stage TNMO) (ie. prostate cancer without metastases)
Patients within one year at the day of randomization from initiation of androgen deprivation therapy with a LHRH agonist (with or without an antiandrogen) and with the intended duration of androgen deprivation therapy of at least 12 months. Patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within two weeks of visit 1
Patients who received any prior bisphosphonate therapy in the past 12 months will be excluded
Patients who are currently receiving diethylstilbesterol (DES) or PC-SPES (treatment for osteoporosis) will be excluded
Patients who have received prior treatment with systemic corticosteroids within the past 12 months will be excluded (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
Other eligibility criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Millennium Therapeutics & Research	Birmingham	Alabama	United States	35205
2	Medical Affiliated Research Center	Huntsville	Alabama	United States	35801
3	Alaska Clinical Research Center	Anchorage	Alaska	United States	99508
4	Advanced Clinical Therapeutics	Tucson	Arizona	United States	85712
5	Donald Gleason, MD	Tucson	Arizona	United States	85712
6	Arkansas Urology	Little Rock	Arkansas	United States	72211
7	Advanced Urology Med. Center	Anaheim	California	United States	92801
8	Atlantic Urological Medical Group	Long Beach	California	United States	90806
9	San Diego Uro. Research	San Diego	California	United States	92101
10	Western Clinical Research	Torrance	California	United States	90505
11	Connecticut Surgical Group	Hartford	Connecticut	United States	06106
12	Grove Hill Urology	New Britain	Connecticut	United States	06052
13	Atlantic Urological Associates	Daytona Beach	Florida	United States	32114
14	University of Miami School of Medicine, Dept. of Urology	Miami	Florida	United States	33176
15	Advanced Research Institute, Inc.	New Port Richey	Florida	United States	34652
16	Urosearch	Ocala	Florida	United States	34470
17	Southeastern Urological Center, PA	Tallahassee	Florida	United States	32308
18	Medisphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
19	The Iowa Clinic, PC, Iowa Urology Research	Des Moines	Iowa	United States	50309
20	Summitt Clinical Research	Owings Mills	Maryland	United States	21117
21	Millennium Medical Center	Southfield	Michigan	United States	48075
22	Quality Clinical Research LLC	Springfield	Nebraska	United States	68059
23	Associated Urologic Specialist, PA	Marlton	New Jersey	United States	08053
24	Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
25	Associates In Urology, LLC	West Orange	New Jersey	United States	07052
26	AccuMed Research Associates	Garden City	New York	United States	11530
27	Urological Surgeons of L.I.	Garden City	New York	United States	11530
28	Staten Island Urological Research, PC	Staten Island	New York	United States	10304
29	The Urology Group	Cincinnati	Ohio	United States	45212
30	Urological Associates, Inc.	Columbus	Ohio	United States	43222
31	Mount Vernon Urological Associates	Mount Vernon	Ohio	United States	43050
32	Oregon Urology Specialists	Eugene	Oregon	United States	97401
33	The Urology Clinic	Portland	Oregon	United States	97210
34	Urologic Associates of Allentown	Allentown	Pennsylvania	United States	18103
35	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
36	Triangle Urological Group	Pittsburgh	Pennsylvania	United States	15212
37	Urologic Surgeons of New England, P.C.	Providence	Rhode Island	United States	02904
38	University Urological Research Institute	Providence	Rhode Island	United States	02906
39	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
40	Integrity Clinical Research, LLC	Germantown	Tennessee	United States	38138
41	Urology San Antonio Research	San Antonio	Texas	United States	78229
42	Salt Lake Research	Salt Lake City	Utah	United States	84124
43	Seattle Urological Associates	Seattle	Washington	United States	98704
44	Rockwood Clinic	Spokane	Washington	United States	99220