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

September 13, 2005
February 10, 2014
May 2002
December 2005   (final data collection date for primary outcome measure)
Our primary outcome variable will be change in spine bone mineral density over one year and change during the second year (or both years).
Same as current
Complete list of historical versions of study NCT00177619 on ClinicalTrials.gov Archive Site
Secondary endpoints will be bone mineral density at the hip and lateral spine.
Same as current
Not Provided
Not Provided
 
Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)
Prevention of Osteoporosis in Men With Prostate Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Prostatic Neoplasms
Drug: Alendronate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177619
5 R01 DK061536, 5 R01 DK061536
Not Provided
Susan L. Greenspan, University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Susan L Greenspan, MD University of Pittsburgh
University of Pittsburgh
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP