Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

December 28, 2007

Start Date ^ICMJE

September 2003

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.

Change History

Complete list of historical versions of study NCT00181584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo [ Time Frame: 3 years ] [ Designated as safety issue: No ]
to assess the safety and tolerability of zoledronic acid. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo
to assess the safety and tolerability of zoledronic acid.

Descriptive Information

Brief Title ^ICMJE

Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Official Title ^ICMJE

Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Brief Summary

The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.

Detailed Description

Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo.
Zometa is administered intravenously over a 15 minute prior once in this one year study.
All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.
All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bone Loss
Prostate Cancer

Intervention ^ICMJE

Drug: Zoledronic acid
Other: Placebo

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

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adenocarcinoma of the prostate
Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months
Corrected serum calcium > 8.4mg/dl and < 10.6mg/dl
Serum creatinine < 2.0mg/dl

Exclusion Criteria:

History of bone metastases by bone scan
Treatment with bisphosphonate within one year
History of metabolic disease
Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00181584

Responsible Party

Matthew Smith, MD, PhD, Massachusetts General Hosptial

Study ID Numbers ^ICMJE

03-194

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Dana-Farber Cancer Institute

Investigators ^ICMJE

Principal Investigator:

Matthew Smith, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP