The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
- Conditions
- Osteogenesis Imperfecta
- Interventions
- Registration Number
- NCT01679080
- Lead Sponsor
- University of Aarhus
- Brief Summary
Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the present study is to investigate the effect of treatment of adult OI patients with bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture risk and quality of life.
The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- clinical diagnosis of osteogenesis imperfecta
- BMD<-1.0 or
- creatinine clearance <30mL/min
- treatment with glucocorticoids > 5mg daily during the last 3 months
- metabolic bone disease or vitamin d deficiency
- liver or kidney disease
- contradictions to zoledronic acid or teriparatide
- increased baseline risk of osteosarcoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No active treatment No active treatment Observation in three years, no treatment Zolendronic acid, 3 yr + placebo teriparatide, 2 yr Zoledronic acid yearly intravenous infusion of 5mg active zoledronic acid in 3 yr teriparatide 2 yr; active zol in 3rd yr Zoledronic acid daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3. teriparatide 2 yr; active zol in 3rd yr Teriparatide daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
- Primary Outcome Measures
Name Time Method Bone Mineral Density (BMD) Three years Dual-energy X-ray absorptiometry scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome.
- Secondary Outcome Measures
Name Time Method Fracture risk Three years Participants are asked to report fractures throughout the study. Medical examination yearly with a focus on possible new fractures. Columnar x-ray before and after the study investigate new fractures.
Trial Locations
- Locations (3)
Department of Endocrinology M
🇩🇰Odense, Denmark
Department of endocrinology
🇩🇰Hvidovre, Denmark
Osteoporosis clinic; department of endocrinology and metabolism
🇩🇰Aarhus, Aarhus C, Denmark