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SMC021 Calcitonin · 2 trials · 2 indications
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.
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).
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).
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months |
| 2 | PLACEBO_COMPARATOR | SMC021 Placebo, orally twice daily during 24 months |
| SMC021- Placebo | PLACEBO_COMPARATOR | SMC021 - placebo |
| Name | Type | Description |
|---|---|---|
| SMC021 Oral Calcitonin | DRUG | 0.8mg SMC021 (Oral Calcitoinin) twice daily |
| SMC021 Placebo | DRUG | Placebo orally, twice daily |
Inclusion Criteria: * Medical history and symptoms of knee osteoarthritis Exclusion Criteria: * 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 t...
SMC021 Calcitonin is an investigational small molecule being studied for osteoarthritis and osteoporosis. It is a form of calcitonin administered orally. The drug is in Phase 3 clinical development for these musculoskeletal conditions.
SMC021 Calcitonin is a calcitonin-based therapy. Calcitonin is a hormone that helps regulate calcium levels and bone metabolism. It is being studied for its potential effects on bone and joint conditions, specifically osteoarthritis and osteoporosis.
SMC021 Calcitonin is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded under the ticker symbol NVS on the New York Stock Exchange.
SMC021 Calcitonin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of osteoarthritis and osteoporosis.
SMC021 Calcitonin has been studied in two completed Phase 3 clinical trials. NCT00486434 evaluated the drug in patients with knee osteoarthritis, enrolling 1,176 participants. NCT00525798 assessed the drug in postmenopausal women with osteoporosis, enrolling 4,665 participants.
SMC021 Calcitonin is an oral formulation of salmon calcitonin. The clinical trials NCT00486434 and NCT00525798 both studied oral salmon calcitonin, which is the active substance in SMC021 Calcitonin.