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

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: zoledronic acid	Phase IV

MedlinePlus related topics:

Cancer Minerals Osteoporosis Prostate Cancer

ChemIDplus related topics:

Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Novartis:

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

Estimated Enrollment:	200
Study Start Date:	April 2003
Estimated Study Completion Date:	April 2005

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063609

Show 44 Study Locations

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CZOL446GUS45, ZENITH
First Received:	July 1, 2003
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00063609
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Prostate Cancer

Bone Loss

Osteoporosis

Bone Mineral Density

Androgen Deprivation Therapy

Study placed in the following topic categories:

Diphosphonates

Zoledronic acid

Prostatic Diseases

Genital Neoplasms, Male

Osteoporosis

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00063609