Expired Study
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Charleston, South Carolina 29425


Purpose:

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.


Study summary:

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


Criteria:

Eligibility Criteria: - 5-14 years of age - Weight 20 kg or greater - History of one or more atraumatic fracture - Sexual development no greater than Tanner II - Osteoporosis by DXA (Diagnosis of high-turnover osteoporosis with no underlying cause (e.g., malignancy, hyperthyroidism, hyperparathyroidism, or vitamin D intoxication) Inclusion Criteria: - Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of >20%). - Bone mineral density by DXA 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) - Parental consent (and patient assent after age 12 years) to participate in the study. - Sexual development at Tanner stage II or less (Prepubertal stage) - Weight 20kg and more Exclusion Criteria: - History of severe gastritis or reflux - Marked kyphoscoliosis or inability to sit or stand for at least 30 minutes. - Abnormalities of the esophagus that delay emptying (e.g., strictures or achalasia) - Hypersensitivity to bisphosphonates - Uncorrected hypocalcemia - History of gastric or duodenal ulcers - Renal dysfunction as indicated by serum Creatinine greater than 1.5 mg/dL - Liver dysfunction as indicated by serum SGPT greater than 2 times upper limit of normal for age or serum total bilirubin greater than 2.0 mg/dL - Diagnosis of osteogenesis imperfecta (including family history) or blue sclerae or deafness - Diagnosis of active rickets, osteomalacia, or bone alkaline phosphatase > 2 times normal for age - Severe gastritis or reflux - Pregnancy - Anorexia Nervosa - 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


NCT ID:

NCT00010439


Primary Contact:

Principal Investigator
Deborah A Bowlby, M.D.
Medical University of South Carolina


Backup Contact:

N/A


Location Contact:

Charleston, South Carolina 29425
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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