Osteogenesis imperfecta
Conditions
Brief summary
The proportion of participants experiencing a clinical fracture validated by x-ray or other imaging, This is an event driven study which will be terminated when 139 participants have experienced an incident clinical fracture validated by x-ray or other imaging. This is expected to have occurred after an average of 62 months follow up.
Detailed description
The total number of clinical fractures experienced by participants validated by x-ray or other imaging., The number of incident vertebral fractures assessed by imaging of the thoracic and lumbar spine., The total number of fractures experienced by participants defined as the combination validated clinical fractures and vertebral fractures and fractures reported by participants, where imaging was not performed, not feasible or where the results were inconclusive., Bone pain assessed by the brief pain inventory (BPI); quality of life as assessed by the SF36 questionnaire; functional status as assessed by the health assessment questionnaire (HAQ) and EuroQol5D (EQ5D) assessment tools, and adverse events, The total number of clinical fractures validated by imaging, incident vertebral fractures, and total number of fractures will be evaluated at the same time as the primary endpoint which on average will be after an average duration of 62 months follow up, Bone pain, health related quality of life and functional status will be evaluated after 12 months, 24 months and at the end of study (approximately 62 months)
Interventions
DRUGAlendronic Acid 70 mg tablets
DRUGFORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen
DRUGRisedronate Sodium 35 mg Film-coated Tablets
DRUGZoledronic Acid Seacross 5 mg/100ml solution for infusion
DRUGFultium-D3 800 IU Capsules
DRUGIbandronic acid Accord 3 mg solution for injection in pre-filled syringe
DRUGDisodium Pamidronate 15mg/ml Concentrate for Solution for Infusion
DRUGCalcichew-D3 500 mg/200 IU Chewable Tablet
DRUGIbandronic acid Sandoz 150 mg Film-coated Tablets
DRUGCLASTEON® 400mg capsules
Sponsors
University Of Edinburgh, NHS Lothian
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants experiencing a clinical fracture validated by x-ray or other imaging, This is an event driven study which will be terminated when 139 participants have experienced an incident clinical fracture validated by x-ray or other imaging. This is expected to have occurred after an average of 62 months follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The total number of clinical fractures experienced by participants validated by x-ray or other imaging., The number of incident vertebral fractures assessed by imaging of the thoracic and lumbar spine., The total number of fractures experienced by participants defined as the combination validated clinical fractures and vertebral fractures and fractures reported by participants, where imaging was not performed, not feasible or where the results were inconclusive., Bone pain assessed by the brief pain inventory (BPI); quality of life as assessed by the SF36 questionnaire; functional status as assessed by the health assessment questionnaire (HAQ) and EuroQol5D (EQ5D) assessment tools, and adverse events, The total number of clinical fractures validated by imaging, incident vertebral fractures, and total number of fractures will be evaluated at the same time as the primary endpoint which on average will be after an average duration of 62 months follow up, Bone pain, health relate | — |
Countries
Denmark, France, Ireland, Netherlands
Outcome results
None listed