Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis

What Was Tested

The trial (phase 3) is built around Calcitonin.

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

SMC021 Placebo, orally twice daily during 24 months.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1176 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

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

Because people in this Calcitonin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 and investigator.

It started in 2007-05 with completion listed for 2010-09.

It ran at 9 sites in Denmark (3), Poland (2), Czechia (1), Estonia (1), Hong Kong (1) and Romania (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months (time frame: Change from baseline to 24 months). Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee (time frame: Change from baseline to 24 months). Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee (time frame: Change from baseline to 24 months).

It also tracked 4 secondary outcomes, for example Changes in Biochemical Markers of Bone & Cartilage Metabolism, Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months, Nature and # of AEs Monitored Continuously During Study and Disease Progression in the Knee Evaluated by MRI.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Calcitonin in 1176 people.

With 1176 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.