A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis

What Was Tested

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

It had two arms (groups): Oral calcitonin at dinner-or bedtime (experimental) and Oral placebo at dinner- or bedtime (experimental).

Intervention: oral placebo at dinnertime or oral placebo at bedtime.

The registry classes the interventions as drug.

More on the Plan

This was a randomized, double-blind, placebo-controlled Phase 2 study conducted entirely in the US.

The subjects were all post-menopausal women whose 10-year risk of major osteoporotic fracture was assessed using the World Health Organization (WHO) Fracture Risk Assessment Tool (FRAX®) algorithm within the first 3 visits.

Eligible, consenting subjects were then enrolled and began a 2- week single-blind placebo run-in phase to determine tolerability.

After the run-in phase, continuing subjects were randomized in a 2:1 ratio to receive oral calcitonin or placebo.

Who Took Part

The registry lists 129 actual participants took part.

It was open to women only aged from 45 years with no upper age limit.

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

Examples of who could join: Female and at least 45 years of age. Serum follicle-stimulating hormone (FSH) levels must be ≥ 30 mIU/mL. A body mass index (BMI) of not greater than 35 (BMI. Bone mineral density (BMD) T-score between -1.0 and - 2.5 at the total hip, femoral neck, trochanter, or lumbar spine. Subjects must give written informed consent after reading the Subject Information and Consent Form and having had the opportunity to discuss the study with the investigator.

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: history of an osteoporotic fracture, defined as a fracture at the wrist, hip, or humerus occurring from a fall at standing height or less; BMD T-Score at any site ≤ -2.5; current treatment (or within 3 months prior to randomization) with hormone replacement therapy.

How the Study Was Run

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

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

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

As a double-blind Calcitonin 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 2011-01 with completion listed for 2012-05.

It ran at 10 sites in United States (10).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo (time frame: Baseline, Week 54).

It also tracked 1 secondary outcome, for example Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Calcitonin in 129 people.

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.