brittle bone disease OI
Conditions
Interventions
24 months of teriparatide followed by a single infusion of zoledronic acid.
Sponsors
ACCORD
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Adult patients age 18 years and above with a clinical diagnosis of OI, Patients willing and able to consent and comply with the study protocol
Exclusion criteria
Exclusion criteria: •Current or previous treatment with an investigational (non-licensed experimental) drug with effects on bone metabolism within two years of screening or treatment with teriparatide within two years of screening., • Contraindication to TPTD or ZA , • Women of childbearing potential not using highly effective methods of contraception (see below), • Pregnancy, • Women that are breastfeeding, • Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractures validated by x-ray or some other form of imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Validated questionnaires: Health Assessment Questionnaire SF-36 Pittsburgh Sleep Quality Index EQ-5D Brief Pain Inventory DNA and serum samples | — |
Countries
Netherlands
Outcome results
None listed