Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00486434|
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : June 28, 2012
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: SMC021 Oral Calcitonin Drug: SMC021 Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Active Comparator: 1
SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months
Drug: SMC021 Oral Calcitonin
0.8mg SMC021 (Oral Calcitoinin) twice daily
Placebo Comparator: 2
SMC021 Placebo, orally twice daily during 24 months
Drug: SMC021 Placebo
Placebo orally, twice daily
- 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 ]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.
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee [ Time Frame: Change from baseline to 24 months ]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 function 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).
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee. [ Time Frame: Change from baseline to 24 months ]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 difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).
- Changes in Biochemical Markers of Bone & Cartilage Metabolism. [ Time Frame: From Baseline to Month 24 ]The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done.
- Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months [ Time Frame: Baseline and Month 24 ]
To assess disease progression of OA affected joints, X-rays of both hands were performed & assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, & joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses.
The AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated.
- Nature and # of AEs Monitored Continuously During Study [ Time Frame: From Baseline to Month 24 ]Adverse events were by system organ class of all patients.
- Disease Progression in the Knee Evaluated by MRI. [ Time Frame: From Baseline to Month 24 ]Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486434
|Pardubice, Czechia, 53002|
|Aalborg, Denmark, 9000|
|Ballerup, Denmark, 2750|
|Vejle, Denmark, 7100|
|Tallinn, Estonia, 10128|
|CCBR Hong Kong|
|Hong Kong, Hong Kong|
|Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2|
|Bialystok, Poland, 15-461|
|Warsaw, Poland, 04703|
|Bucharest, Romania, 030463|
|Study Chair:||Bente J Riis, M.D.||Nordic Bioscience A/S|