A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women

What Was Tested

The trial (phase 2) is built around Calcitonin.

It had four arms (groups): Part 1 Double Blind Oral rsCT Tablet (experimental), Part 1, Double-blind Oral Placebo Tablet (placebo comparator), Part 2 Open label, Oral rsCT tablet (experimental) and Part 2, Open Label Fortical Nasal Spray (active comparator).

Intervention: Oral rsCT tablet given once 4 hours after evening meal.

Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal.

Intervention: Oral rsCT tablet given once 2 hours after evening meal.

The registry classes the interventions as drug.

More on the Plan

See protocol summary for information.

Who Took Part

12 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 five years since last menses). Age greater than or equal to 45 years old and less than or equal to 70 years old. Plasma CTx-1 greater than or equal to 0.25 ng/ml. Total calcium, phosphorus, and magnesium 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

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Calcitonin and who got the comparison, which limits bias.

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

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

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

It started in 2008-12 with completion listed for 2009-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example AUCInhibition=Hours*%P.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Calcitonin in 12 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.