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Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis



Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis

For Condition: Osteoporosis
Status: Not yet recruiting
Sponsor(s): FDA Office of Orphan Products Development , Medical University of South Carolina
Synopsis: OBJECTIVES: I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.
Details: PROTOCOL OUTLINE: Patients receive oral alendronate sodium daily for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 5 Years/14 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of high-turnover osteoporosis with no underlying cause (e.g., malignancy, hyperthyroidism, hyperparathyroidism, or vitamin D intoxication) Bone mineral density by DEXA at 2 standard deviations (SD) below normal mean for age (Z-score at least 2 SD below normal mean at the lumbar spine or hip) History of at least 1 atraumatic fracture, or evidence of at least 1 compression fracture on radiograph of the spine (reduction of at least 20%) No marked kyphoscoliosis or inability to sit or stand for at least 30 minutes No active rickets, osteomalacia, or bone alkaline phosphatase more than 2 times normal for age No osteogenesis imperfecta (including family history) or blue sclerae --Prior/Concurrent Therapy-- Prior course of prednisone allowed No concurrent prednisone except inhaled steroids No concurrent high-dose glucocorticoids No concurrent salmon calcitonin No other concurrent bisphosphonates No concurrent long-term anti-seizure medication --Patient Characteristics-- Hepatic: - SGPT no greater than 2 times upper limit of normal for age - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL - No uncorrected hypocalcemia Other: - No deafness - Weight more than 30 kg - Sexual development no greater than Tanner II - No severe gastritis or reflux - No gastric or duodenal ulcers - No abnormalities of the esophagus that delay emptying (e.g., strictures or achalasia) - No hypersensitivity to bisphosphonates
Total Enrollment: 12

Location and Contact Information:

Overall Study Official:
L.Key,  Study Chair,  Medical University of South Carolina


Additional Information:
Study ID Numbers:  199/15705;  MUSC-FDR001847
Study Start Date: 
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010439

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