Overview

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

Status:
Completed
Trial end date:
2002-09-01
Target enrollment:
0
Participant gender:
All
Summary
OBJECTIVES: I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Treatments:
Alendronate
Calcium
Calcium Carbonate
Cholecalciferol
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