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

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”

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.

PROTOCOL OUTLINE:

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

Intervention(s) in this Clinical Trial

• Drug: Alendronate
  • Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1 Alendronate for 12 months
  • Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.

Primary Measures

• Number of Participants With Increased Bone Mineral Density
  • Time Frame: at 12 months
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: Before and 12 months after treatment with alendronate
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 14 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Medical University of South Carolina Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00010439

Study ID Number: 199/15705

ClinicalTrials.gov Identifier: NCT00010439

Health Authority: United States: Food and Drug Administration