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.

Condition	Treatment or Intervention	Phase
Osteoporosis	Drug: alendronate sodium	Phase II

PROTOCOL OUTLINE: Patients receive oral alendronate sodium daily for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Ages Eligible for Study:  5 Years   -   14 Years,  Genders Eligible for Study:  Both

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

Study chairs or principal investigators

L. Lyndon Key, Jr.,  Study Chair,  Medical University of South Carolina   

Study ID Numbers:  199/15705; MUSC-FDR001847
Record last reviewed:  February 2001
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010439
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09