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

Tracking Information
First Received Date ^ICMJE	July 1, 2003
Last Updated Date	November 20, 2009
Start Date ^ICMJE	April 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 18, 2006)	Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00063609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 18, 2006)	Percent changes in bone mineral density of the total hip biochemical markers of bone turnover at one year
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Official Title ^ICMJE	The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy
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.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Drug: zoledronic acid
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	200
Completion Date	April 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00063609
Responsible Party
Study ID Numbers ^ICMJE	CZOL446GUS45, ZENITH
Study Sponsor ^ICMJE	Novartis Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP