The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,030
0.8mg SMC021, twice daily
0.8mg Placebo, twice daily
Achieve Clinical Research, LLC
Tuscaloosa, Alabama, United States
Center for Healthy Aging
Sacramento, California, United States
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
The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
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
WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).
Time frame: Change from baseline to 24 months
Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX I/creatinine and CTX-II/creatinine. These biomarkers were analysed in order to assess the cartilage and bone turonver ratio to baseline at month 24.
Time frame: From baseline to 24 months
Knee Disease Progression Assessed by MRI
Knee cartilage volume and thickness was assessed by MRI in patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site.
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Northwestern Center for Clinical Research
Chicago, Illinois, United States
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, United States
Thurston Arthritis Research Center
Chapel Hill, North Carolina, United States
Rheumatology Clinical Research Unit
Beachwood, Ohio, United States
Hospital Universitaire St. Luc, UCL 5390
Brussels, Belgium
Centre de Rhumatologie St-Louis
Sainte-Foy (Québec), Canada
CCBR Czech
Pardubice, Czechia
CCBR Aalborg
Aalborg, Denmark
...and 8 more locations
Time frame: From baseline to month 12 and month 24
Questionnaire to Assess Function and Physical Activity
Function and physical activity were assessed by assessed by WOMAC function sub-score in the signal knee. The criteria for assessment of the functional classification according to the American Rheumatism Association (ARA) were as follows (Hochberg et al 1992): I. Completely able to perform usual activities of daily living (self-care, vocational and avocational) II. Able to perform usual self-care and vocational activities, but limited in avocational activities. III. Able to perform usual self-care activities, but limited in vocational and avocational activities. IV. Limited ability to perform usual self-care activities, vocational and avocational activities. Self-care activities included dressing, feeding, bathing, grooming, and toileting. Avocational (recreational and/or leisure) and vocational (work, school, homemaking) activities were patient-desired and age- and sex-specific.
Time frame: From baseline to months 1, 6, 12 and 24
Questionnaire to Assess Stiffness in the Signal Knee.
WOMAC's stiffness subscore was used to assess the stiffness in the signal knee. WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of joint stiffness for when performing each daily function listed in the questionnaire. 0 is no stiffness (best), 100 is extreme stiffness (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 200. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less stiffness). Patients were instructed not to take analgesics for 3 days prior to the WOMAC test.
Time frame: Baseline to month 24
Questionnaire to Assess Health-related Quality of Life
Health-related quality of life was assessed by the EQ-5D questionnaire, which is a patient questionnaire for measure of health, developed by the EuroQol Group.The EQ-5D questionnaire was administered to patients in order to measure change in health-related quality of life (HRQoL) over 2 years. The subjects marks on a VAS scale from 0 to 100 the number that best describes their health today (0 is worst imaginable health state and 100 is best imaginable health state). The change from baseline in the EQ-5D VAS was calculated.
Time frame: From baseline to month 24
Questionnaire to Assess Pain
Pain was assessed by the WOMAC subscore in the signal knee by visit. Patients assessed their current pain level using a 100 mm visual analogue scales (VAS) by placing an X on the line that best describes his/her pain, where 0 equaled "No Pain" and 100 equaled "Worst Pain Imaginable". Patients were instructed not to take analgesics for 3 days prior to the VAS.
Time frame: Baseline, month 1, month 6, month 12, month 24