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

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Alendronate

• Registration Number: NCT00010439
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

PROTOCOL OUTLINE:

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

Study Timeline

• Study Start: 2000-09
• Study First Submitted QC: 2001-02-01
• Study First Submitted: 2001-02-02
• Study First Posted: 2001-02-02
• Primary Completion: 2003-10
• Study Completion: 2008-11
• Results First Submitted: 2009-06-03
• Results First Submitted QC: 2010-08-25
• Results First Posted: 2010-09-17
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-21
• Last Update Posted: 2010-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 Alendronate for 12 months	Alendronate	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 Outcome Measures

Name	Time	Method
Number of Participants With Increased Bone Mineral Density	at 12 months	Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)

Secondary Outcome Measures

Name	Time	Method
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.	Before and 12 months after treatment with alendronate	Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States