MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis

What Was Tested

In this phase 4 trial, researchers set out to test Teriparatide.

The aim of this study is the quantitative determination of bone-specific microRNAs in the serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic therapy.

It had four arms (groups): Group 1 - DMAB (active comparator), Group 2 - TPTD (active comparator), Group 3 - DMAB (active comparator) and Group 4 - TPTD (active comparator).

Postmenopausal women without type 2 diabetes mellitus treated with denosumab.

Postmenopausal women with type 2 Diabetes mellitus treated with teriparatide.

Postmenopausal women with type 2 diabetes mellitus treated with denosumab.

The registry classes the interventions as drug.

More on the Plan

Primarily the influence of the therapeutic treatment on the microRNA concentration in the serum (treatment-response) and the relation between microRNA serum levels and changes of the bone mineral density will be investigated.

These data will help to examine the use of microRNAs as novel diagnostic biomarkers for the diagnosis of osteoporosis and targeted therapeutic treatment of patients.

Who Took Part

26 actual participants took part.

It was open to women only aged from 60 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 60-80 years. T-score according to DXA: \<-2.5. Indication for osteoporosis therapy according to international guidelines.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: diabetes mellitus type 1; renal insufficiency iii-v °; cirrhosis hepatis (child b or higher).

How the Study Was Run

The set-up was non-randomized, crossover and open-label.

Each person switched between Teriparatide and the comparison at some point, usually with a gap in between.

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

It started in 2017-03-01 with completion listed for 2022-09-01.

It ran at 1 site in Austria.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): detection of microRNA concentration in serum (time frame: 24 months).

It also tracked 1 secondary outcome, for example microRNAs and changes in bone metabolism under treatment.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Teriparatide in 26 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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