Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)

What Was Tested

This registered phase 3 trial tested Calcitonin.

It had two arms (groups): 1 (active comparator) and 2 (placebo comparator).

SMC021 Oral Calcitonin.

SMC021 Placebo.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1030 actual participants took part.

It was open to people of any sex aged from 51 years up to 80 years.

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

Examples of who could join: Medical history and symptoms of knee osteoarthritis.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: any other disease or medication affecting the bone or cartilage; any clinical signs or laboratory evidence diseases, which in the investigator's opinion would preclude the participant from adhering to the protocol or completing the trial.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

Neither the participants nor the staff measuring them knew who was on Calcitonin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-06 with completion listed for 2011-05.

It ran at 18 sites in United States (6), Denmark (3), Poland (2), Belgium (1), Canada (1) and Czechia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months (time frame: Change from baseline to 24 months). Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index (time frame: Change from baseline to 24 months).

It also tracked 6 secondary outcomes, for example Bone & Cartilage Metabolism Biochemical Marker Change (Percentage), Knee Disease Progression Assessed by MRI, Questionnaire to Assess Function and Physical Activity, Questionnaire to Assess Stiffness in the Signal Knee, Questionnaire to Assess Health-related Quality of Life and Questionnaire to Assess Pain.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Calcitonin in 1030 people.

With 1030 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Calcitonin compound page, all human trials.