A Study for Patients With Osteoporosis

What Was Tested

The trial (phase 3) is built around Teriparatide and Calcitonin.

The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis.

It had two arms (groups): A (experimental) and B (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 364 actual participants took part.

It was open to people of any sex aged from 40 years up to 85 years.

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

Examples of who could join: Clinical diagnosis of osteoporosis. No other severe disabling conditions. Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5. Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: history of a disease that affects bone metabolism; history or presence of liver disease; history or presence of kidney disease.

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.

Nothing was hidden in this open-label Teriparatide study: the participants and staff both knew the treatment.

It started in 2006-12 with completion listed for 2008-07.

It ran at 5 sites in China (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women (time frame: Baseline to 24 weeks).

It also tracked 5 secondary outcomes, for example Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women, Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women, Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men, Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men and Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide and Calcitonin in 364 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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