A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

What Was Tested

This registered phase 3 trial tested Calcitonin.

It had two arms (groups): 1 (active comparator) and SMC021- Placebo (placebo comparator).

SMC021 - Oral Calcitonin.

SMC021 - placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 4665 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.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites; more than 2 prevalent vertebral fractures (genant et al, 15); evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures).

How the Study Was Run

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

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

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 Calcitonin.

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

It started in 2007-03 with completion listed for 2011-08.

It ran at 16 sites in United States (3), Denmark (3), Brazil (1), China (1), Czechia (1) and Estonia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Patients With New Vertebral Fractures (time frame: From baseline to month 36).

It also tracked 1 secondary outcome, for example Number of Patients With Non-vertebral Fractures.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Calcitonin in 4665 people.

With 4665 participants it is a large trial for this field.

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.