Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Alendronate
Intervention description: Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.
Intervention MeSH terms: Alendronate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 5 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: arthritis & connective tissue diseases; idiopathic juvenile osteoporosis; rare disease

Summary:

      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.
    

Eligibility 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