Prevention of Osteoporosis in Men With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00048841
First received: November 8, 2002
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Prostate Cancer
Osteoporosis
Hypogonadism
Drug: alendronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prevention of Osteoporosis in Men With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

Secondary Outcome Measures:
  • BMD at the hip and lateral spine

Estimated Enrollment: 112
Study Start Date: May 2002
Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048841

Locations
United States, Pennsylvania
Osteoporosis Prevention & Treatment Center
Pittsburgh, Pennsylvania, United States, 15213-3221
Sponsors and Collaborators
Investigators
Principal Investigator: Susan L. Greenspan, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00048841     History of Changes
Other Study ID Numbers: DK61535 (completed)
Study First Received: November 8, 2002
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Male
Osteoporosis
Prostate cancer
Hypogonadism
Bisphosphonates
Bone mineral density

Additional relevant MeSH terms:
Hypogonadism
Osteoporosis
Prostatic Neoplasms
Gonadal Disorders
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014