Phase 2
N=10
Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00010439 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Number of Participants With Increased Bone Mineral Density — 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alendronate (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Increased Bone Mineral Density |
10 | — |
| SECONDARY 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. |
9; 1; 9; 9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00010439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.