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A phase III randomized, multicenter, single-blind, parallel-group, active-controlled, non-inferiority trial was performed to investigate the safety and efficacy of a novel formulation of glucosamine sulfate (1500 mg) and bovine chondroitin sulfate (1200 mg) combination compared to the reference product in individuals with knee osteoarthritis.
The novel formulation of a
fixed-dose combo of glucosamine sulfate and bovine chondroitin sulfate
demonstrated non-inferiority to the reference product to treat knee
osteoarthritis, with an elevated responder rate and an excellent tolerability
profile.
A
phase III randomized, multicenter, single-blind, parallel-group,
active-controlled, non-inferiority trial was performed to investigate the
safety and efficacy of a novel formulation of glucosamine sulfate (1500 mg) and
bovine chondroitin sulfate (1200 mg) combination compared to the reference
product in individuals with knee osteoarthritis.
The study arm incorporated 627 patients suffering from knee osteoarthritis. Participants were randomized to receive either glucosamine sulfate/chondroitin sulfate or the reference product for about 24 weeks. The absolute alteration in Western Ontario and McMaster Universities (WOMAC) score was the major efficacy outcome.
The secondary outcomes were (i)
WOMAC total and subscale scores, (ii) overall evaluation of the disease by the
participant and the investigator, (iii) SF-12 score, (iv) rescue medication
usage, and (v) Outcome Measures in Rheumatology Clinical Trials and
Osteoarthritis Research Society International (OMERACT-OARSI) response rate to
the therapy.
The mean decline of WOMAC pain score and the rate of OMERACT-OARSI responders in both the groups is depicted below:
The difference between the adjusted means of both therapies confirmed the noninferiority of glucosamine sulfate/chondroitin sulfate versus reference product. Improvement was noted in stiffness, pain, physical function and total WOMAC score, and in overall osteoarthritis evaluation by the participant and the researcher for both the arms.
No improvement was witnessed in
SF-12. Headache and alteration in glucose tolerance were the most common
therapy-associated adverse events.
Management of osteoarthritis of the
knee with the novel formulation of
bovine chondroitin and glucosamine sulfate is advantageous with a good
safety profile.
Advances in Rheumatology
Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial
Andrea Barranjard Vannucci Lomonte et al.
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