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

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide.

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.

It had three arms (groups): Zolendronic acid, 3 yr + placebo teriparatide, 2 yr (experimental), teriparatide 2 yr; active zol in 3rd yr (experimental) and No active treatment (placebo comparator).

Observation in three years, no treatment.

The registry classes the interventions as drug and other.

Who Took Part

9 actual participants took part.

It was open to people of any sex aged from 22 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinical diagnosis of osteogenesis imperfecta.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: metabolic bone disease or vitamin d deficiency; liver or kidney disease; contradictions to zoledronic acid or teriparatide.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2012-11 with completion listed for 2020-07-01.

It ran at 3 sites in Denmark (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Bone Mineral Density (BMD) (time frame: Three years).

It also tracked 1 secondary outcome, for example Fracture risk.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.