Status:
COMPLETED
Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 andro...
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 mort...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00177619
Start Date
May 1 2002
End Date
December 1 2005
Last Update
February 11 2014
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213