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

This study has been completed.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181584
First received: September 9, 2005
Last updated: July 9, 2013
Last verified: July 2013
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181584     History of Changes
Other Study ID Numbers: 03-194
Study First Received: September 9, 2005
Last Updated: July 9, 2013
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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Diphosphonates
Androgens
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014