A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

What Was Tested

The trial (phase 4) is built around Teriparatide for osteoporosis and bone density.

It had 1 arm (groups): Teriparatide (experimental).

The registry classes the interventions as drug.

More on the Plan

As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment.

This extension will allow for collection of additional bone quality data.

In Canada, the use of teriparatide is currently approved for 18 months.

Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

Who Took Part

Enrollment: 35 actual participants took part.

It was open to women only aged from 45 years up to 85 years.

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

Examples of who could join: Postmenopausal (after the "change of life") women with osteoporosis. Between the ages of 45-85. Have low bone mass as determined by a bone density test. Could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have a metal implant or have had a hip replacement in either hip which might affect results of study; currently have active or suspected diseases that affect the bone, other than osteoporosis; have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values.

How the Study Was Run

The set-up was single-group and open-label.

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 2007-11 with completion listed for 2010-10.

It ran at 6 sites in United States (5) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint (time frame: Baseline, 18 months).

It also tracked 16 secondary outcomes, for example Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint, Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint, Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint, Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint, Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint and Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Teriparatide in 35 people with osteoporosis and bone density.

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

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

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