At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
Alendronatedrug
Likely dose
Alendronate 35 or 70 mg orally weekly (dose based on body weight) for 12 monthsAI-extracted
Key inclusion· 6
- ✓Age 5-14 years
- ✓Weight at least 20 kg
- ✓History of one or more atraumatic fractures OR radiographic evidence of spine compression fractures (>20% reduction)
- ✓Bone mineral density Z-score ≤-2 SD below mean at lumbar spine or hip on DXA
Key exclusion· 11
- ✕History of severe gastritis or reflux
- ✕Esophageal abnormalities that delay emptying (strictures or achalasia)
- ✕History of gastric or duodenal ulcers
- ✕Hypersensitivity to bisphosphonates
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Alendronate for Osteoporosis. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2000
First PostedFeb 2001
Primary CompletionOct 2003
Study CompletionNov 2008
TodayJul 2026
First PostedFeb 2, 2001
Enrollment StartSep 1, 2000
Primary CompletionOct 1, 2003
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 25.4 years ago
Interventions
Alendronatedrug
Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.