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

University of Aarhus

Status and phase: Terminated; Phase 2

Conditions: Osteogenesis Imperfecta

Treatments: Drug: Zoledronic acid; Other: No active treatment; Drug: Teriparatide

Study type: Interventional

Funder types: Other

Identifiers

NCT01679080

TreatOI

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 22 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups, including a placebo group

Zolendronic acid, 3 yr + placebo teriparatide, 2 yr

Experimental group

Description:

yearly intravenous infusion of 5mg active zoledronic acid in 3 yr

Treatment:

Drug: Zoledronic acid

teriparatide 2 yr; active zol in 3rd yr

Experimental group

Description:

daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.

Treatment:

Drug: Teriparatide

Drug: Zoledronic acid

No active treatment

Placebo Comparator group

Description:

Observation in three years, no treatment

Treatment:

Other: No active treatment