Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

What Was Tested

This registered phase 3 trial tested Teriparatide.

It had three arms (groups): 1 (experimental), 2 (experimental) and 3 (placebo comparator).

Placebo plus calcium and vitamin D.

The registry classes the interventions as drug.

Who Took Part

1637 actual participants took part.

It was open to women only aged from 30 years up to 85 years.

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

Examples of who could join: Ambulatory, postmenopausal women. A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.

The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or paget's disease); current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism; currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Teriparatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 1996-08 with completion listed for 1999-04.

It ran at 17 sites in United States (1), Argentina (1), Australia (1), Austria (1), Belgium (1) and Canada (1).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 1637 people.

With 1637 participants it is a large trial for this field.

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.