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Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
This study has been completed.
Sponsor:
Medical University of South Carolina
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
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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 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:
Genetics Home Reference related topics:
juvenile primary osteoporosis
osteoporosis-pseudoglioma syndrome
Drug Information available for:
Alendronate sodium
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 ]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 ]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 (Child) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00010439
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
Additional 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 ( Other Grant/Funding Number: FDA ) |
| Study First Received: | February 2, 2001 |
| Results First Received: | June 3, 2009 |
| Last Updated: | October 21, 2010 |
Keywords provided by Medical University of South Carolina:
|
arthritis & connective tissue diseases idiopathic juvenile osteoporosis rare disease |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Alendronate Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 26, 2017