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

Purpose

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.

Condition	Intervention	Phase
Bone Loss Prostate Cancer	Drug: Zoledronic acid Other: Placebo	Phase II

MedlinePlus related topics:

Cancer Minerals Prostate Cancer

Drug Information available for:

Zoledronic acid

U.S. FDA Resources

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

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

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	60
Study Start Date:	September 2003
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator	Drug: Zoledronic acid Given intravenously once.
Group 2: Placebo Comparator	Other: Placebo Given intravenously once.

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181584

Locations


United States, Massachusetts
	Massachusetts General Hospital
	Boston, Massachusetts, United States, 02114
	Dana-Farber Cancer Institute
	Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Investigators


Principal Investigator:	Matthew Smith, MD	Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hosptial ( Matthew Smith, MD, PhD )
Study ID Numbers:	03-194
First Received:	September 9, 2005
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00181584
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Androgen deprivation therapy

bone loss

prostate cancer

Zoledronic Acid

Zometa

Study placed in the following topic categories:

Diphosphonates

Zoledronic acid

Prostatic Diseases

Genital Neoplasms, Male

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 November 30, 2008

Sponsors and Collaborators:	Massachusetts General Hospital Dana-Farber Cancer Institute
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00181584