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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?

Osteogenesis Imperfecta

Study Interventions

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

Study Arms

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

Study Status

Active, not recruiting

Start Date: November 2012

Completed Date: December 2021

Phase: Phase 2

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01679080

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