A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women

What Was Tested

In this phase 2 trial, researchers set out to test Calcitonin.

It had three arms (groups): rsCTA (experimental), rsCTB (experimental) and Fortical (active comparator).

Oral Tablet.

Oral Tablet.

Nasal Spray.

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to women only aged from 45 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Postmenopausal female, in good health (at least 5 years since last menses). Age ≥45 and ≤70. Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL. Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range. Willing and able to comply with all study requirements.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: history of parathyroid, thyroid, pituitary or adrenal diseases; history of musculoskeletal disease; history of cancer within 5 years of enrollment other than basal cell carcinoma.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Calcitonin and the comparison in turn, acting as their own control.

Everyone knew when Calcitonin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-02 with completion listed for 2008-04.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Calcitonin in 24 people.

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 Calcitonin compound page, all human trials.