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Prevention of Osteoporosis in Men With Prostate Cancer

Phase 3
18 Years
Not Enrolling
Prostatic Neoplasms

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Trial Information

Prevention of Osteoporosis in Men With Prostate Cancer

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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).

Principal Investigator

Susan L Greenspan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:

5 R01 DK061536



Start Date:

May 2002

Completion Date:

December 2005

Related Keywords:

  • Prostatic Neoplasms
  • Prostatic neoplasms
  • Bisphosphonates
  • Hypogonadism
  • Neoplasms
  • Osteoporosis
  • Prostatic Neoplasms



University of Pittsburgh Pittsburgh, Pennsylvania  15261