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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

February 2, 2001
October 21, 2010
September 2000
October 2003   (final data collection date for primary outcome measure)
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)
Not Provided
Complete list of historical versions of study NCT00010439 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
Drug: Alendronate
Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.
Other Name: Fosamax
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.
Intervention: Drug: Alendronate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2008
October 2003   (final data collection date for primary outcome measure)

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
Both
5 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010439
199/15705, FD-R-001847-01
Yes
Deborah A Bowlby, MD., Assistant Professor, Medical University of South Carolina
Medical University of South Carolina
Merck Sharp & Dohme Corp.
Principal Investigator: Deborah A Bowlby, M.D. Medical University of South Carolina
Medical University of South Carolina
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP