Phase 3
Completed N=1,176
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
Source: ClinicalTrials.gov NCT00486434 ↗Enrolled (actual)
1,176
Serious AEs
16.1%
Results posted
Jun 2012
Primary outcomePrimary: Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months. — -0.188; -0.198 mm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months. |
-0.188; -0.198 | — |
| PRIMARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee |
-124.0; -109.0 | — |
| PRIMARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee. |
-390.0; -299.5 | — |
| SECONDARY Changes in Biochemical Markers of Bone & Cartilage Metabolism. |
41.358; 62.883; -9.134; 1.785; -8.959; 8.311 | — |
| SECONDARY Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months |
0.40; 0.40; 0.45; 0.62; 0.83; 0.82 | — |
| SECONDARY Nature and # of AEs Monitored Continuously During Study |
548; 520; 1068; 18; 16; 34 | — |
| SECONDARY Disease Progression in the Knee Evaluated by MRI. |
2.90; 0.26; 4.79; 1.94; 1.9921; 0.4343 | — |
Eligibility Criteria
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 to the Protocol or completing the trial.
Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00486434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.