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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181584
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 11, 2013
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Bone Loss Prostate Cancer Drug: Zoledronic acid Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
Study Start Date : September 2003
Actual Primary Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Group 1 Drug: Zoledronic acid
Given intravenously once.
Other Name: Zometa

Placebo Comparator: Group 2 Other: Placebo
Given intravenously once.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo [ Time Frame: 3 years ]
  2. to assess the safety and tolerability of zoledronic acid. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181584

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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
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Principal Investigator: Matthew Smith, MD Massachusetts General Hospital
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Responsible Party: Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital Identifier: NCT00181584    
Other Study ID Numbers: 03-194
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Matthew R. Smith, MD, PhD, Massachusetts General Hospital:
Androgen deprivation therapy
bone loss
prostate cancer
Zoledronic Acid
Additional relevant MeSH terms:
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Prostatic Neoplasms
Bone Diseases, Metabolic
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs