Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Alendronate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Medical University of South Carolina Official(s) and/or principal investigator(s):
Deborah A Bowlby, M.D., Principal Investigator, Affiliation: Medical University of South Carolina
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.
Clinical Details
Official title: A Non-Randomized, Open-Label, Prospective, Non-Controlled, 12-Month Clinical Trial to Determine the Effects of Alendronate 35 or 70 mg/Week Depending Upon Body Weight, in Children and Adolescent With IJO
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Increased Bone Mineral Density
Secondary outcome: Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.
Detailed description:
PROTOCOL OUTLINE:
Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the
absence of disease progression or unacceptable toxicity.
Eligibility
Minimum age: 5 Years.
Maximum age: 14 Years.
Gender(s): Both.
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
Locations and Contacts
Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information
Starting date: September 2000
Last updated: October 21, 2010
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