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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2007 by Massachusetts General Hospital. Recruitment status was Active, not recruiting

First Received on September 9, 2005. Last Updated on December 28, 2007 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborator:	Dana-Farber Cancer Institute
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00181584

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Cancer Minerals Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

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
Active Comparator: Group 1	Drug: Zoledronic acid Given intravenously once. Other Name: Zometa
Placebo Comparator: Group 2	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

No publications provided

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

Keywords provided by Massachusetts General Hospital:

Androgen deprivation therapy
bone loss
prostate cancer
Zoledronic Acid
Zometa

Additional relevant MeSH terms:

Bone Diseases, Metabolic
Prostatic Neoplasms
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male

Prostatic Diseases
Androgens
Zoledronic acid
Diphosphonates
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 12, 2012