Bone Effects of Teriparatide Following Alendronate

What Was Tested

In this phase 3 trial, researchers set out to test Teriparatide for osteoporosis and bone density.

Patients will include postmenopausal, osteoporotic women who have been treated long term (at least 36 months) with alendronate, as well as postmenopausal, osteoporotic women who have never been treated for osteoporosis.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 66 planned participants were the target.

It was open to women only aged from 55 years with no upper age limit.

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

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: history of bone metabolic diseases, paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2003-09 with completion listed for 2006-11.

It ran at 2 sites in Austria (1) and Czechia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Teriparatide in 66 people with osteoporosis and bone density.

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

More context: the Teriparatide compound page, Osteoporosis and bone density research.