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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Alendronate

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