Phase 4
Completed N=18
Bisphosphonate Therapy for Osteogenesis Imperfecta
osteogenesis imperfecta · Osteoporosis · Paget Disease of Bone
Source: ClinicalTrials.gov NCT00159419 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Bone Mineral Density — -1.3; -1.1 z-score
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density |
-1.3; -1.1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of OI, as defined by genetic analysis revealing a defect of type I collagen, OR by bone mineral density (BMD) <2.5 standard deviations (SD) for age plus two of the following:
- Family history of OI
- Frequent fractures
- Blue sclerae
- Multiple wormian bones on skull x-ray
- Hearing disturbance
- Dentinogenesis imperfecta
- Age between 3 and 21 years at the start of the study period.
- Children must be able to swallow whole tablets
- Parents of children must be able to understand protocol and give informed consent.
Exclusion Criteria
- Therapy with bisphosphonates during the past 12 months.
- Other "non-traditional" therapy for OI in the last 6 months, such as growth hormone or anabolic steroids.
- Other chronic diseases besides OI that interfere with bone morphology or gastrointestinal absorption
Data sourced from ClinicalTrials.gov (NCT00159419). 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. Informational only — not medical advice.