A Study for the Transdermal Application of Teriparatide

What Was Tested

This registered phase 2 trial tested Teriparatide.

The primary purpose of this study is to help answer the following research questions: 1.

How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are). 2.

It had four arms (groups): one (active comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Who Took Part

The registry lists 233 actual participants took part.

It was open to women only aged from 55 years up to 80 years.

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

Examples of who could join: Ambulatory, postmenopausal women. Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.5. Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver. Able to be reached by telephone for follow-up contact between visits.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: abnormal laboratory values for albumin and alkaline phosphatase; laboratory values outside the ranges defined in the protocol for the following: serum calcium, intact parathyroid hormone (ipth), 25 hydroxyvitamin d, and 24-hour urine calcium; use of a pacemaker.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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.

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

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2009-11 with completion listed for 2011-09.

It ran at 18 sites in Hungary (7), Romania (4), Estonia (3), Mexico (3) and Argentina (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months (time frame: Baseline, 12 Months).

It also tracked 15 secondary outcomes, for example Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months, Time Course Change of BMD Response at the Lumbar Spine, Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP), Percent Change From Baseline of C-Terminal Telopeptide (CTX), Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month and Convenience/Ease of Use Questionnaire (CEUQ).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 233 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, all human trials.