Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease

Inclusion Criteria

• •PROTOCOL ENTRY CRITERIA:
• •-Disease Characteristics--
• •Diagnosis of type 1 Gaucher's disease enzymatically proven to have acid beta glucosidase deficiency
• •Must have been on stable dose (8-60 U/kg/every 2 weeks) of alglucerase enzyme therapy (Cerezyme or Ceredase) for at least 24 months
• •Lumbar spine bone density below the mean for age, sex, and race
• •-Prior/Concurrent Therapy--
• •At least 6 months since prior medications that directly affect skeletal metabolism including, but not limited to, bisphosphonates, calcitonin, parathyroid hormone, or estrogen
• •-Patient Characteristics--
• •Renal: No chronic renal failure; No recurrent renal stones
• •Esophageal: No history of dysphagia; No frequent heartburn; No esophagitis requiring treatment
• •Other: No untreated hyperthyroidism or hypothyroidism; No concurrent hyperparathyroidism; No concurrent malignancy; No history of alcohol or drug abuse; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception