The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab

What Was Tested

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

This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.

It had two arms (groups): Standard Clinical Practice Regimen (active comparator) and Experimental (cyclic) regimen (experimental).

Standard Clinical Practice (Daily) Regimen: 18 months of daily subcutaneous Forteo followed by denosumab therapy for 18 months (18 months of Forteo then 3 injections of Prolia at 18, 24 and 30 months).

The registry classes the interventions as drug.

More on the Plan

In order to maximize the early anabolic effect with teriparatide (TPTD), and to avoid the development of tachyphylaxis to the continued daily administration of TPTD beyond 6 months, cyclic therapy might be optimal.

Since Denosumab (Prolia) is a potent antiresorptive agent with a rapid off-effect, it might be the optimal agent to help maximize bone gains with cyclic TPTD/antiresorptive therapy.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to women only aged from 45 years with no upper age limit.

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

The full record lists 0 inclusion and 17 exclusion criteria; among the exclusions: the use of drugs known to affect skeletal or calcium homeostasis; multiple vertebral fractures or severe lumbar degenerative changes with fewer than 2 evaluable lumbar vertebrae; current use of anti-resorptive medicines.

How the Study Was Run

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

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

The Teriparatide group and the comparison group ran side by side rather than switching.

Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-08 with completion listed for 2018-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: spine bone density (time frame: 3 years).

It also tracked 1 secondary outcome, for example bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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