Osteogenesis imperfecta
Conditions
Interventions
Trade Name: Forsteo
Product Code: H05AA02
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administra
Sponsors
Bente Langdahl, consultant, ass. professor, PhD, DMSc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inklusion criterias • Patients with OI type I and IV • Age 22 - 70 years • Informed consent o Low BMD (T-score =/=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exklusion criterias • Creatinine clearance < 30 mL/min • Previous treatment with PTH. Previous treatment with antiresorptives is not an exclusion criteria, but will be used for stratification of the patients • Treatment with glucocorticoids = 5mg daily during the last 3 months. • Metabolic bone disease or vitamin D deficiency. • Liver- or kidney disease • Existing contra indications for treatment with zoledronic acid or PTH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A descriptive investigation of adult Danish patients with OI is at the moment being conducted. In this study the underlying genetic background is compared with the phenotype. The aim of the present study is to investigate the effect of treatment of adult patients with OI with bisphosphonate (zoledronic acid)and parathyroid hormone (PTH) compared with placebo on bone mass, fracture risk and quality of life. The hypothesis is tested in a randomized, placebo controlled, double blind trial. The following endpoints have been identified: Primary endpoint: 1. The effect of the treatments on bone mineral density (BMD) at the lumbar spine. ;Secondary Objective: Secondary endpoints: 1. The effect of the treatments on bone mineral density (BMD) at the hip (femoral neck and total hip) 2. The effect of the treatments on fracture risk 3. The effect of the treatments on bone turnover evaluated by biochemical markers before, during and after treatment. 4. The effect of the treatments on bone architecture evaluated by histomorphometry after 2 years treatment. 5. The effect of the treatments on bone architecture investigated by QCT and pQCT before and after 2 years treatment. ;Primary end point(s): Primary endpoint: 1. The effect of the treatments on bone mineral density (BMD) at the lumbar spine. ;Timepoint(s) of evaluation of this end point: DXA evaluation at 6, 12, 18, 24, 30 and 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: 1. The effect of the treatments on bone mineral density (BMD) at the hip (femoral neck and total hip) 2. The effect of the treatments on fracture risk 3. The effect of the treatments on bone turnover evaluated by biochemical markers before, during and after treatment. 4. The effect of the treatments on bone architecture evaluated by histomorphometry after 1 years treatment. 5. The effect of the treatments on bone architecture investigated by QCT and pQCT before, after 1 year of treatment and after treatment. ;Timepoint(s) of evaluation of this end point: ad 1: DXA evaluation at 6, 12, 18, 24, 30 and 36 months ad 2: Continuously and at 36 months ad 3: before, during (at 1, 3, 6, 12, 18, 24 and 30 months) and after treatment. ad 4: after year 1 ad 5: before treatment, after 1 year of treatment and after treatment. | — |
Countries
Denmark
Contacts
Public ContactOsteoporoseklinikken
Aarhus University Hospital
Outcome results
None listed