Clinical trial · Interventional
Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)
Prevention of Osteoporosis in Men With Prostate Cancer
NCT00177619CI-TRIAL-00013717completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alendronate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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).
Secondary outcomes (1)
- measure
- Secondary endpoints will be bone mineral density at the hip and lateral spine.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.