Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis

What Was Tested

The trial (phase 2) is built around Teriparatide.

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

ViaDerm transdermal delivery.

Add Via-Derm transdermal delivery.

Subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

The registry lists 104 actual participants took part.

It was open to women only aged from 55 years up to 85 years.

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

Examples of who could join: Post-menopausal women aged between 55 to 85 years (inclusive). Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ≤-2.5 SD. Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values. Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease. Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan.

The full record lists 7 inclusion and 0 exclusion criteria.

How the Study Was Run

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

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

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

It started in 2008-04 with completion listed for 2009-03.

It ran at 10 sites in Hungary (5), Israel (3) and Czechia (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP) (time frame: Baseline, 96 days).

It also tracked 10 secondary outcomes, for example Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.), Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection, Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection, Percentage of patients with serum total calcium above the upper limit of normal range, Number of participants with hPTH (1-34) specific antibody immune response and Draize score for erythema and edema.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 104 people.

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.