The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

• Status: Terminated
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Diphosphonates; Teriparatide; Zoledronic Acid

Criteria

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