CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Alendronate +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Diagnosis of OI confirmed by genetic analysis showing type I collagen defect, OR BMD <2.5 SD below age mean plus ≥2 supporting clinical features (family history, frequent fractures, blue sclerae, wormian bones, hearing loss, or dentinogenesis imperfecta)
  • ✓Age 3 to 21 years at study start
  • ✓Ability to swallow whole tablets
Key exclusion· 3
  • ✕Bisphosphonate therapy within the past 12 months
  • ✕Non-traditional OI therapy (e.g., growth hormone or anabolic steroids) within the last 6 months
  • ✕Other chronic diseases affecting bone morphology or gastrointestinal absorption

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00159419
NCT00159419Phase 4Completed
CompareCT.gov

Bisphosphonate Therapy for Osteogenesis Imperfecta

Indiana University·interventional·Posted Sep 12, 2005·Updated Jun 14, 2017

In Brief

A Phase 4 clinical trial evaluating Alendronate and Pamidronate for Osteogenesis Imperfecta and 2 related conditions. Completed, enrolled 18 participants.

Detailed Summary

The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteogenesis Imperfecta, Osteoporosis, Paget Disease of Bone
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartAug 1, 1999
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 20.8 years ago

Interventions

Alendronatedrug

Pamidronatedrug