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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00010439
First received: February 2, 2001
Last updated: October 21, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
 Drug: Alendronate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Number of Participants With Increased Bone Mineral Density [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.
Enrollment: 10
Study Start Date: September 2000
Study Completion Date: November 2008
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Alendronate
Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.
Other Name: Fosamax

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
Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010439

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Deborah A Bowlby, M.D. Medical University of South Carolina
  More Information

Publications:
1. Key LL Jr., Ries w, Madyastha P, Reed F: Juvenile Osteoporosis: recognizing the risk. J Pediatr Endocrinol Metab. 2003 May; 16 Suppl 3:683-6, PMID: 12795371 2. P Madyastha, W Ries, B Hollis, F Reed, L Key. Alendronate improved bone mineral density in patients with juvenile osteoporosis. JBMR 20:Suppl 1, page S400, 2005.

Responsible Party: Deborah A Bowlby, MD., Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00010439     History of Changes
Other Study ID Numbers: 199/15705, FD-R-001847-01
Study First Received: February 2, 2001
Results First Received: June 3, 2009
Last Updated: October 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
arthritis & connective tissue diseases
idiopathic juvenile osteoporosis
rare disease

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
 Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 01, 2015