Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
- Conditions
- Osteoarthritis
- Interventions
- Drug: SMC021 Placebo
- Registration Number
- NCT00486434
- Lead Sponsor
- Nordic Bioscience A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1176
- Medical history and symptoms of knee osteoarthritis
- Any other disease or medication affecting the bone or cartilage.
- Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.
Other protocol defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 SMC021 Placebo SMC021 Placebo, orally twice daily during 24 months 1 SMC021 Oral Calcitonin SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months
- Primary Outcome Measures
Name Time Method Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months. 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 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. 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).
- Secondary Outcome Measures
Name Time Method Changes in Biochemical Markers of Bone & Cartilage Metabolism. 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 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 From Baseline to Month 24 Adverse events were by system organ class of all patients.
Disease Progression in the Knee Evaluated by MRI. 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.
Trial Locations
- Locations (9)
Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2
🇵🇱Bialystok, Poland
CCBR Poland
🇵🇱Warsaw, Poland
CCBR Czech
🇨🇿Pardubice, Czechia
CCBR Ballerup
🇩🇰Ballerup, Denmark
CCBR Estonia
🇪🇪Tallinn, Estonia
CCBR Romania
🇷🇴Bucharest, Romania
CCBR Aalborg
🇩🇰Aalborg, Denmark
CCBR Vejle
🇩🇰Vejle, Denmark
CCBR Hong Kong
🇭🇰Hong Kong, Hong Kong