Osteogenesis Imperfecta | The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
Osteogenesis Imperfecta research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Zoledronic acidantiresorptive and calcium and vitamin D
Drug:Teriparatideanabolic and calcium and vitamin D
Other:No active treatmentCalcium and vitamin D
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Zolendronic acid, 3 yr + placebo teriparatide, 2 yryearly intravenous infusion of 5mg active zoledronic acid in 3 yr
teriparatide 2 yr; active zol in 3rd yrdaily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
No active treatmentObservation in three years, no treatment
Active, not recruiting
Start Date: November 2012
Completed Date: December 2021
Phase: Phase 2
Primary Outcome: Bone Mineral Density (BMD)
Secondary Outcome: Fracture risk
Study sponsors, principal investigator, and references
Principal Investigator: Bente Langdahl, MD
Lead Sponsor: University of Aarhus