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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMC021 Oral Calcitonin | Drug | 0.8mg SMC021 (Oral Calcitoinin) twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 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. | Change from baseline to 24 months |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore 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 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). | Change from baseline to 24 months |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore 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 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). | Change from baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Biochemical Markers of Bone & Cartilage Metabolism. | 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. | From Baseline to Month 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bente J Riis, M.D. | Nordic Bioscience A/S | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCBR Czech | Pardubice | 53002 | Czechia | |||
| CCBR Aalborg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42092979 | Derived | Hannani MT, Frederiksen P, Karsdal MA, Bager CL, Bihlet AR, Tunblad K, Oberg F, Collins JE, Kraus VB, Hunter DJ, Bacardit J, Bay-Jensen AC, Thudium CS. Therapeutic subtypes of knee osteoarthritis: differential treatment effects among predicted endotypes in past clinical trials. Arthritis Res Ther. 2026 May 7;28(1):133. doi: 10.1186/s13075-026-03825-7. | |
| 41764561 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Arm | 0.8mg SMC021 Oral Calcitonin tablet twice daily |
| FG001 | Placebo Arm | 1 SMC021 Placebo tablet twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Arm | 0.8mg SMC021 Oral Calcitonin tablet twice daily |
| BG001 | Placebo Arm | 1 SMC021 Placebo tablet twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 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. | The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis. | Posted | Mean | Standard Deviation | mm | Change from baseline to 24 months |
|
From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Arm | 0.8mg SMC021 Oral Calcitonin tablet twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bente Juel Riis, Medical Director | Nordic Bioscience A/S | +4522901317 | bjr@nordicbioscience.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SMC021 Placebo |
| Drug |
Placebo orally, twice daily |
|
| Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months |
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. |
| Baseline and Month 24 |
| Nature and # of AEs Monitored Continuously During Study | Adverse events were by system organ class of all patients. | From Baseline to Month 24 |
| Disease Progression in the Knee Evaluated by MRI. | 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. | From Baseline to Month 24 |
| Aalborg |
| 9000 |
| Denmark |
| CCBR Ballerup | Ballerup Municipality | 2750 | Denmark |
| CCBR Vejle | Vejle | 7100 | Denmark |
| CCBR Estonia | Tallinn | 10128 | Estonia |
| CCBR Hong Kong | Hong Kong | Hong Kong |
| Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2 | Bialystok | 15-461 | Poland |
| CCBR Poland | Warsaw | 04703 | Poland |
| CCBR Romania | Bucharest | 030463 | Romania |
| Bay-Jensen AC, Mohamed K, Frederiksen P, Bihlet A, Thudium C, Henriksen K, Karsdal M. Weight loss ameliorates symptoms of osteoarthritis and is correlated with alterations in soluble bone and cartilage markers: an analysis of patient-reported outcomes and biomarkers. BMC Rheumatol. 2026 Feb 28;10(1):30. doi: 10.1186/s41927-026-00628-w. |
| 32249039 | Derived | Bihlet AR, Bjerre-Bastos JJ, Andersen JR, Byrjalsen I, Karsdal MA, Bay-Jensen AC. Clinical and biochemical factors associated with risk of total joint replacement and radiographic progression in osteoarthritis: Data from two phase III clinical trials. Semin Arthritis Rheum. 2020 Dec;50(6):1374-1381. doi: 10.1016/j.semarthrit.2020.03.002. Epub 2020 Mar 15. |
| 31481084 | Derived | Bihlet AR, Byrjalsen I, Bay-Jensen AC, Andersen JR, Christiansen C, Riis BJ, Karsdal MA. Associations between biomarkers of bone and cartilage turnover, gender, pain categories and radiographic severity in knee osteoarthritis. Arthritis Res Ther. 2019 Sep 3;21(1):203. doi: 10.1186/s13075-019-1987-7. |
| 29343266 | Derived | Bihlet AR, Byrjalsen I, Bay-Jensen AC, Andersen JR, Christiansen C, Riis BJ, Valter I, Karsdal MA, Hochberg MC. Identification of pain categories associated with change in pain in patients receiving placebo: data from two phase 3 randomized clinical trials in symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2018 Jan 17;19(1):17. doi: 10.1186/s12891-018-1938-5. |
| 25582279 | Derived | Karsdal MA, Byrjalsen I, Alexandersen P, Bihlet A, Andersen JR, Riis BJ, Bay-Jensen AC, Christiansen C; CSMC021C2301/2 investigators. Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials. Osteoarthritis Cartilage. 2015 Apr;23(4):532-43. doi: 10.1016/j.joca.2014.12.019. Epub 2015 Jan 9. |
| 20932224 | Derived | Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11. |
| Protocol Violation |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Death |
|
| Personal reasons |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Active Arm |
0.8mg SMC021 Oral Calcitonin tablet twice daily |
| OG001 | Placebo Arm | 1 SMC021 Placebo tablet twice daily |
|
|
| Primary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore 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 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). | The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis. | Posted | Median | Inter-Quartile Range | Units on a scale | Change from baseline to 24 months |
|
|
|
| Primary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore 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 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 number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis. | Posted | Median | Inter-Quartile Range | Units on a scale | Change from baseline to 24 months |
|
|
|
| Secondary | Changes in Biochemical Markers of Bone & Cartilage Metabolism. | 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. | ITT Population. The number analyzed in some rows differs from the overall number analyzed due to missing values from patients who prematurely discontinued. | Posted | Mean | Standard Deviation | percentage of change | From Baseline to Month 24 |
|
|
|
| Secondary | Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months | 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. | About 15% of the ITT population had hand OA at baseline and only these subjects were included in the X-ray assessments.The AUSCAN questionnaire was administered to all the patients at sites in Denmark, the Czech Republic, and Romania. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Month 24 |
|
|
|
| Secondary | Nature and # of AEs Monitored Continuously During Study | Adverse events were by system organ class of all patients. | ITT population. A patient with multiple occurrences of a TEAE under one treatment is counted only once in the AE category for that treatment. | Posted | Number | Number of AEs by system organ class | From Baseline to Month 24 |
|
|
|
| Secondary | Disease Progression in the Knee Evaluated by MRI. | 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. | MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania. | Posted | Mean | Standard Deviation | percentage of change | From Baseline to Month 24 |
|
|
|
| 100 |
| 585 |
| 548 |
| 585 |
| EG001 | Placebo Arm | 1 SMC021 Placebo tablet twice daily | 88 | 584 | 520 | 584 |
| Bone graft | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Coronary artery dilatation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Accidental death | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Device malfunction | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lyme disease | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nerve injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Uterine leimyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cauda equina syndrome | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urethral prolapse | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary retension | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Peau d´orange | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abscess drainage | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cardial pacemaker insertion | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastric bypass | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lipoma excision | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Radical hysterectomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Thyroidectomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Viral infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
| Serum Osteocalcin (ng/mL) |
|
|
| 24-h urine CTX-I/creatinine (µg/mmol) |
|
|
| 24-h urine CTX-II/creatinine (ng/mmol) |
|
|
| Total JSN |
|
|
| Total cyst/erosions |
|
|
| Total osteophytes, JSN and cyst/erosions |
|
|
| AUSCAN total score |
|
|
|
| Cardiac disorders |
|
| Congenital, familial and genetic disorders |
|
| Ear and labyrinth disorders |
|
| Endocrine disorders |
|
| Eye disorders |
|
| Gastrointestinal disorders |
|
| General disorders and administration site condit. |
|
| Hepatobiliary disorders |
|
| Immune system disorders |
|
| Infections and infestations |
|
| Injury, poisoning and procedural complications |
|
| Investigations |
|
| Metabolism and nutrition disorders |
|
| Musculoskeletal and connective tissue disorders |
|
| Neoplasms benign, malignant and unspecified |
|
| Nervous system disorders |
|
| Psychiatric disorders |
|
| Renal and urinary disorders |
|
| Reproductive system and breast disorders |
|
| Respiratory, thoracic and mediastinal disorders |
|
| Skin and subcutaneous tissue disorders |
|
| Surgical and medical procedures |
|
| Vascular disorders |
|
| Total cartilage volume m24 |
|
|
| Total cartilage thickness m12 |
|
|
| Total cartilage thickness m24 |
|
|