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Prevention of Osteoporosis in Men With 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: NCT00048841
Recruitment Status : Completed
First Posted : November 13, 2002
Last Update Posted : March 2, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
The purpose of this two year study is to examine the safety and effectiveness of alendronate (Fosamax) for the prevention of bone loss in men with prostate cancer who are on therapy to lower their testosterone levels. All men will receive appropriate calcium and vitamin D supplements and one to two years of alendronate therapy. Bone density tests will be done every six months.

Condition or disease Intervention/treatment Phase
Prostate Cancer Osteoporosis Hypogonadism Drug: alendronate Phase 3

Detailed Description:
Prostate cancer is the most common visceral malignancy and second leading cause of cancer death in men. While androgen ablation therapy is the cornerstone of treatment for more advanced stage disease, recent studies suggest the advantage of introducing androgen deprivation much earlier. Because androgens are essential in maintaining skeletal integrity in men, androgen deprivation therapy constitutes a major risk factor for male osteoporosis. We have previously demonstrated that men on chronic androgen deprivation therapy have up to 20% loss of bone. Our hypotheses are that: 1) chronically increased bone resorption induced by long term androgen deprivation therapy in men with prostate cancer can be reversed with once weekly bisphosphonate; 2) the improvement in bone mass with bisphosphonate therapy will be reflected by changes in biochemical markers of bone turnover and will allow us to predict who will respond to therapy; and 3) following termination of bisphosphonate therapy, bone mass will be maintained despite the absence of antiresorptive therapy. To address these hypotheses, we will enroll 84 men with stage D0 prostate cancer who have been on chronic androgen deprivation therapy in a two year, double blind, placebo controlled, randomized, modified crossover clinical design. During the first year, subjects will be randomized to bisphosphonate therapy or placebo. During the second year, all subjects who were on placebo will receive active treatment and all subjects who were on active treatment will be randomly assigned to continue therapy or change to placebo. To evaluate the effect of bisphosphonate on preventing bone loss, we will assess bone mass of the spine, total hip, total body, and forearm by dual-energy X-ray absorptiometry. For hypothesis 2, we will assess markers of bone resorption and formation to determine if early changes in markers are associated with long term changes in bone mass. For hypothesis 3, we will continue to follow bone mass and biochemical markers of bone turnover between months 12 and 24 to examine rates of change when antiresorptive therapy is terminated. Few data are available on the prevention of bone loss in men on androgen deprivation therapy. This study will examine a preventive strategy, the potential mechanism of bone loss, the ability of biochemical markers to predict bone mass, and skeletal outcomes when antiresorptive therapy is withdrawn.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Prevention of Osteoporosis in Men With Prostate Cancer
Study Start Date : May 2002
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. PA spine BMD over 1 year
  2. Change in PA spine BMD over 2nd year

Secondary Outcome Measures :
  1. BMD at the hip and lateral spine

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men age 50-85
  • Stage D0 prostate cancer
  • On androgen deprivation therapy

Exclusion Criteria:

  • Renal failure
  • Hyperthyroidism
  • Cushing's syndrome
  • Metabolic bone disease
  • Use of glucocorticoids
  • Use of certain anticonvulsants
  • On osteoporosis therapies
  • Nonprostate cancers

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): NCT00048841

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United States, Pennsylvania
Osteoporosis Prevention & Treatment Center
Pittsburgh, Pennsylvania, United States, 15213-3221
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Susan L. Greenspan, MD University of Pittsburgh
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00048841    
Other Study ID Numbers: DK61535 (completed)
First Posted: November 13, 2002    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Prostate cancer
Bone mineral density
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs