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Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)

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ClinicalTrials.gov Identifier: NCT00177619
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 11, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Susan L. Greenspan, University of Pittsburgh

Brief Summary:
The overall goal of this proposal is to determine the effectiveness and safety of once weekly alendronate (Fosamax) in the prevention and treatment of osteoporosis in men with prostate cancer on androgen deprivation therapy and to evaluate maintenance of bone mass following termination of therapy after one year.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Alendronate Phase 3

Detailed Description:

While osteoporosis in women is recognized as a major public health problem, osteoporosis in men also has a profound clinical impact. Men over the age of 75 who sustain hip fractures have a higher mortality than women of the same age (30% versus 9%). Hip fractures in men account for one-third of all hip fractures. In 1995, male osteoporosis accounted for $2.7 billion in health care costs -- nearly one-third of the overall cost of osteoporosis. Alendronate has been shown to improve bone mass and decrease vertebral fractures in men with osteoporosis.

Prostate cancer is the most common visceral malignancy and the second leading cause of death in American men. Almost all men who progress to late stage disease are treated with androgen deprivation therapy for life, resulting in a 5-fold increased risk of hip fractures and a 13-fold increased risk of all osteoporosis fractures. Several studies suggest the merit of inducing androgen deprivation much earlier in the course of therapy for prostate cancer. It is therefore quite likely that androgen deprivation strategies will be employed with increasing frequency in patients with less advanced disease, resulting in longer life expectancy but greater bone loss.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prevention of Osteoporosis in Men With Prostate Cancer
Study Start Date : May 2002
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Our primary outcome variable will be change in spine bone mineral density over one year and change during the second year (or both years).

Secondary Outcome Measures :
  1. Secondary endpoints will be bone mineral density at the hip and lateral spine.


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Men age 18 and older with stage Do prostate cancer (as defined by asymptomatic disease, rising PSA, and negative bone scans) following attempted curative surgery and/or radiation
  • Androgen deprivation therapy (gonadotropin releasing hormone agonists, lutenizing hormone releasing hormone agonists, testosterone antagonists, orchiectomy) for at least 6 months for treatment of prostate cancer

Exclusion Criteria:

  • History of any illness known to affect bone and mineral metabolism (renal failure, hepatic failure, Paget's disease, osteogenesis imperfecta, osteomalacia)
  • Non-prostate cancer diagnosed within last 5 years (treated superficial basal and squamous cell carcinoma excepted)
  • Hyperparathyroidism
  • Malabsorption
  • Treatment with medications known to affect bone metabolism (chronic high-dose corticosteroid therapy for at least 6 months, thyroid hormone with TSH <0.1 micrograms, antiseizure medications)
  • Active peptic ulcer
  • Inability to sit upright or stand for at least 30 minutes
  • Kidney stones in the past 5 years
  • 24-hour urine calcium value >400 mg/24 hours
  • Esophageal stricture or achalasia
  • Hyperthyroidism
  • Evidence of chronic liver disease (including alcoholism)
  • Treatment within past year for osteoporosis (calcitonin, fluoride, bisphosphonates)
  • History of atraumatic fractures, previous fracture due to a fall from standing height or lesser trauma, or clinical osteoporosis
  • Metastatic prostate cancer
  • Inability to provide written informed consent

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 ClinicalTrials.gov identifier (NCT number): NCT00177619


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Susan L Greenspan, MD University of Pittsburgh

Responsible Party: Susan L. Greenspan, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177619     History of Changes
Other Study ID Numbers: 5R01DK061536 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Susan L. Greenspan, University of Pittsburgh:
Prostatic neoplasms
Bisphosphonates
Hypogonadism

Additional relevant MeSH terms:
Prostatic Neoplasms
Osteoporosis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs