November 19, 2014

Oral Salmon Calcitonin Shows No Clinical Benefit in Symptomatic Knee Osteoarthritis

By Nicola Parry

BOSTON -- November 19, 2014 -- A new tablet form of salmon calcitonin (sCT) failed to produce reproducible clinical benefits in phase 3 trials in patients with symptomatic knee osteoarthritis (OA), researchers said here at the 2014 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).

According to Morten Karsdal, PhD, Nordic Bioscience, Biomarkers and Research, Herlev, Denmark, in earlier preclinical and clinical studies, sCT has been shown to reduce the amount of bone and cartilage damage that occurs in OA.

With this in mind, Dr. Karsdal and colleagues conducted 2 randomised, double-blind, multicentre, placebo-controlled phase 3 studies to investigate its efficacy and safety in the treatment of patients with OA of the knee. For these trials, sCT was produced in tablet form with a carrier to improve its gastrointestinal absorption -- as such, it represented the first protein developed for oral administration and evaluation in phase 3 studies.

The 2 trials involved a total of 2,206 patients with OA of the knee who were experiencing pain and structural damage due to their condition. Patients were randomised to receive either oral sCT 0.8 mg twice daily or placebo.

The primary outcomes were changes in joint space width (JSW) and changes in pain and knee function.

At 24 months, the researchers found no significant difference in JSW in either of the 2 studies, as measured by x-ray. They did find that oral sCT significantly improved Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores (P < .0001), and reduced bone and joint damage as measured by biomarkers (P = .0003) in one trial. However, Dr. Karsdal noted that this beneficial effect was not repeated in the second study.

“The lessons learned from these phase 3 clinical studies may be used to design better studies for OA, by selecting subpopulations that may better match the mode of action of different interventions,” said Dr. Karsdal. “We have designed novel and more potent molecules that we currently are developing for obesity, type 2 diabetes, and osteoarthritis.”

Funding for this study was provided by Nordic Bioscience.

[Presentation title: Treatment of Symptomatic Knee Osteoarthritis With Oral Salmon Calcitonin: Results From Two Phase 3 Randomized Clinical Trials. Abstract 2230]
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