A Randomized, Double-blind Placebo-controlled, Single-joint Study to Assess the Effect of Choline-Stabilized Orthosilicic Acid (ch-OSA) on symptoms of Knee Osteoarthritis

Bio Minerals NV0 sites166 target enrollmentOctober 15, 2015

Overview

Registry

who.int

Start Date

October 15, 2015

End Date

July 20, 2012

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Bio Minerals NV

•1\. Aged between 50 and 75 years
•2\. Females must be either postmenopausal, surgically sterile or use an approved form of birth control.
•3\. OA of the knee as confirmed by radiography (weight\-bearing, antero\-posterior radiograph of the target knee: Kellgren and Lawrence grade II and III) during the screening visit or by a recent radiograph (\< 6 months before baseline)
•4\. Primary (idiopathic) OA of one or both knees for at least 12 weeks prior to administration of study dietary supplement based on the American College of Rheumatology criteria. In addition to pain in the knee, at least 3 of the following 6 characteristics has to be present:
•4\.1\. Over 50 years of age
•4\.2\. Less than 30 minutes of morning stiffness
•4\.3\. Crepitus on active motion
•4\.4\. Bony tenderness
•4\.5\. Bony enlargement
•4\.6\. No palpable warmth of synovium

•1\. Subject unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols
•2\. Poor general health interfering with compliance or assessment
•3\. Unlikely to co\-operate fully in the study
•4\. Participating in another clinical trial in the last 90 days
•5\. Pregnancy or breastfeeding
•6\. Morning stiffness \> 30 minutes in duration
•7\. Subjects with a swollen or warm joint thought to be secondary to gout, pseudo gout or sepsis
•8\. Secondary OA of the target knee including Paget’s disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemachromatosis, Wilson’s disease and primary osteochondromatosis
•9\. Significant injury to the target joint within 6 months of trial start
•10\. Disease of spine or lower extremity joints of sufficient degree to affect assessment of the target joint