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

Completed · Phase 2

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00010439

Run by

Medical University of South Carolina

People needed

10

Starts

2000-09-01

Expected to finish

2008-11-01

Last updated by the study team

2010-11-08

Who can join

Age: 5 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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