Trial · NCT00486434
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
NCT00486434, Phase 3, Completed, Nordic Bioscience A/S; results first posted 2012-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis. Trials, record NCT00486434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00486434
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
- NCT number
- NCT00486434
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,176 participants, actual
- Lead sponsor
- Nordic Bioscience A/S
- Conditions
- Osteoarthritis
- Interventions
- SMC021 Oral Calcitonin, SMC021 Placebo
- First posted
- 2007-06-14
- Last updated
- 2019-04-26
- Results first posted
- 2012-06-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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). |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | Nature and # of AEs Monitored Continuously During Study | From Baseline to Month 24 | Adverse events were by system organ class of all patients. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 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. | mm | MEAN |
| PRIMARY | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee | Change from baseline to 24 months | 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. | Units on a scale | MEDIAN |
| PRIMARY | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee. | Change from baseline to 24 months | 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. | Units on a scale | MEDIAN |
| SECONDARY | Changes in Biochemical Markers of Bone & Cartilage Metabolism. | From Baseline to Month 24 | ITT Population. The number analyzed in some rows differs from the overall number analyzed due to missing values from patients who prematurely discontinued. | percentage of change | MEAN |
| SECONDARY | Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months | Baseline and Month 24 | 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. | Scores on a scale | MEAN |
| SECONDARY | Nature and # of AEs Monitored Continuously During Study | From Baseline to Month 24 | ITT population. A patient with multiple occurrences of a TEAE under one treatment is counted only once in the AE category for that treatment. | Number of AEs by system organ class | NUMBER |
| SECONDARY | Disease Progression in the Knee Evaluated by MRI. | From Baseline to Month 24 | MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania. | percentage of change | MEAN |
Source ClinicalTrials.gov
Results by group107
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months. | Active Arm | -0.188 | Standard Deviation 0.5626 | mm | |
| Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months. | Placebo Arm | -0.198 | Standard Deviation 0.5069 | mm | |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee | Active Arm | -124.0 | Inter-Quartile Range -391 to 218 | Units on a scale | |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee | Placebo Arm | -109.0 | Inter-Quartile Range -410 to 349 | Units on a scale | |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee. | Active Arm | -390.0 | Inter-Quartile Range -1307 to 783 | Units on a scale | |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee. | Placebo Arm | -299.5 | Inter-Quartile Range -1342 to 915 | Units on a scale | |
| Changes in Biochemical Markers of Bone & Cartilage Metabolism. | Active Arm | Serum CTX-I (ng/mL) | 41.358 | Standard Deviation 68.1153 | percentage of change |
| Changes in Biochemical Markers of Bone & Cartilage Metabolism. | Placebo Arm | Serum CTX-I (ng/mL) | 62.883 | Standard Deviation 65.7225 | percentage of change |
| Changes in Biochemical Markers of Bone & Cartilage Metabolism. | Active Arm | Serum Osteocalcin (ng/mL) | -9.134 | Standard Deviation 22.1368 | percentage of change |
| Changes in Biochemical Markers of Bone & Cartilage Metabolism. | Placebo Arm | Serum Osteocalcin (ng/mL) | 1.785 | Standard Deviation 22.8324 | percentage of change |
1 to 10 of 107Source ClinicalTrials.gov
See all 107 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Arm | 588 | |
| Overall Study | STARTED | Placebo Arm | 588 | |
| Overall Study | COMPLETED | Active Arm | 394 | |
| Overall Study | COMPLETED | Placebo Arm | 454 | |
| Overall Study | NOT COMPLETED | Active Arm | 194 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 134 |
Source ClinicalTrials.gov
Adverse events354
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Active Arm | 89 | 585 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo Arm | 93 | 584 | |
| other | Hot flush | Vascular disorders | Active Arm | 104 | 585 | |
| other | Hot flush | Vascular disorders | Placebo Arm | 24 | 584 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Active Arm | 62 | 585 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo Arm | 59 | 584 | |
| other | Nausea | Gastrointestinal disorders | Active Arm | 82 | 585 | |
| other | Nausea | Gastrointestinal disorders | Placebo Arm | 18 | 584 | |
| other | Hypertension | Vascular disorders | Active Arm | 46 | 585 | |
| other | Hypertension | Vascular disorders | Placebo Arm | 52 | 584 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Arm | ||
| Total, all-cause mortality | Placebo Arm | ||
| Total, other adverse events | Active Arm | 548 | 585 |
| Total, other adverse events | Placebo Arm | 520 | 584 |
| Total, serious adverse events | Active Arm | 100 | 585 |
| Total, serious adverse events | Placebo Arm | 88 | 584 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Active Arm vs Placebo Arm: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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