Osteogenesis Imperfecta
Conditions
Keywords
Drug therapy, Adult
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.
Interventions
DRUGZoledronic acid
antiresorptive and calcium and vitamin D
DRUGTeriparatide
anabolic and calcium and vitamin D
OTHERNo active treatment
Calcium and vitamin D
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of osteogenesis imperfecta * BMD\<-1.0 or
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed