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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan L. Greenspan, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177619
First received: September 13, 2005
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Prostatic Neoplasms
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: Treatment
Official Title: Prevention of Osteoporosis in Men With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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

Estimated Enrollment: 120
Study Start Date: May 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  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: NCT00177619

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Susan L Greenspan, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Susan L. Greenspan, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177619     History of Changes
Other Study ID Numbers: 5 R01 DK061536, 5 R01 DK061536
Study First Received: September 13, 2005
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Prostatic neoplasms
Bisphosphonates
Hypogonadism

Additional relevant MeSH terms:
Neoplasms
Osteoporosis
Prostatic Neoplasms
Bone Diseases
Bone Diseases, Metabolic
Genital Diseases, Male
Genital Neoplasms, Male
Musculoskeletal Diseases
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014