Trial · NCT00704847
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)
NCT00704847, Phase 3, Terminated, Nordic Bioscience A/S; results first posted 2012-09-12
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 (OA 2 Study). Trials, record NCT00704847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00704847
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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 (OA 2 Study)
- NCT number
- NCT00704847
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,030 participants, actual
- Lead sponsor
- Nordic Bioscience A/S
- Conditions
- Osteoarthritis
- Interventions
- Oral Salmon Calcitonin, Oral Salmon Calcitonin (Placebo)
- First posted
- 2008-06-25
- Last updated
- 2019-04-24
- Results first posted
- 2012-09-12
- Limitations and caveats
- The study showed an underexposure to calcitonin compared to what was expected from phase I trials.
Source ClinicalTrials.gov
Registered outcomes8
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 Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 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 | Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index | 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 pain 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). |
| Secondary | Bone & Cartilage Metabolism Biochemical Marker Change (Percentage). | From baseline to 24 months | The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX I/creatinine and CTX-II/creatinine. These biomarkers were analysed in order to assess the cartilage and bone turonver ratio to baseline at month 24. |
| Secondary | Knee Disease Progression Assessed by MRI | From baseline to month 12 and month 24 | Knee cartilage volume and thickness was assessed by MRI in 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. |
| Secondary | Questionnaire to Assess Function and Physical Activity | From baseline to months 1, 6, 12 and 24 | Function and physical activity were assessed by assessed by WOMAC function sub-score in the signal knee. The criteria for assessment of the functional classification according to the American Rheumatism Association (ARA) were as follows (Hochberg et al 1992): I. Completely able to perform usual activities of daily living (self-care, vocational and avocational) II. Able to perform usual self-care and vocational activities, but limited in avocational activities. III. Able to perform usual self-care activities, but limited in vocational and avocational activities. IV. Limited ability to perform usual self-care activities, vocational and avocational activities. Self-care activities included dressing, feeding, bathing, grooming, and toileting. Avocational (recreational and/or leisure) and vocational (work, school, homemaking) activities were patient-desired and age- and sex-specific. |
| Secondary | Questionnaire to Assess Stiffness in the Signal Knee. | Baseline to month 24 | WOMAC's stiffness subscore was used to assess the stiffness 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 joint stiffness for when performing each daily function listed in the questionnaire. 0 is no stiffness (best), 100 is extreme stiffness (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 200. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less stiffness). Patients were instructed not to take analgesics for 3 days prior to the WOMAC test. |
| Secondary | Questionnaire to Assess Health-related Quality of Life | From baseline to month 24 | Health-related quality of life was assessed by the EQ-5D questionnaire, which is a patient questionnaire for measure of health, developed by the EuroQol Group.The EQ-5D questionnaire was administered to patients in order to measure change in health-related quality of life (HRQoL) over 2 years. The subjects marks on a VAS scale from 0 to 100 the number that best describes their health today (0 is worst imaginable health state and 100 is best imaginable health state). The change from baseline in the EQ-5D VAS was calculated. |
| Secondary | Questionnaire to Assess Pain | Baseline, month 1, month 6, month 12, month 24 | Pain was assessed by the WOMAC subscore in the signal knee by visit. Patients assessed their current pain level using a 100 mm visual analogue scales (VAS) by placing an X on the line that best describes his/her pain, where 0 equaled "No Pain" and 100 equaled "Worst Pain Imaginable". Patients were instructed not to take analgesics for 3 days prior to the VAS. |
Source ClinicalTrials.gov
Outcomes8
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 Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 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 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis. | mm | MEAN |
| PRIMARY | Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index | 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 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis. | Units on a scale | MEAN |
| SECONDARY | Bone & Cartilage Metabolism Biochemical Marker Change (Percentage). | From baseline to 24 months | The number of participants analysed for these outcomes were a total of 150 subjects from the intent-to-treat (ITT) population evenly distributed across sites, all with completed baseline as well as all follow-up visits. | percentage of change | MEAN |
| SECONDARY | Knee Disease Progression Assessed by MRI | From baseline to month 12 and month 24 | Subset of patients from the sites in Ballerup (Denmark), Czech Republic and Romania | percentage of change | MEAN |
| SECONDARY | Questionnaire to Assess Function and Physical Activity | From baseline to months 1, 6, 12 and 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. | percentage of change | MEAN |
| SECONDARY | Questionnaire to Assess Stiffness in the Signal Knee. | 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. | percentage of change | MEAN |
| SECONDARY | Questionnaire to Assess Health-related Quality of Life | 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. | percentage of change | MEAN |
| SECONDARY | Questionnaire to Assess Pain | Baseline, month 1, month 6, month 12, 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. | percentage of change | MEAN |
Source ClinicalTrials.gov
Results by group40
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 Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months | SMC021 Oral Calcitonin | -0.32 | Standard Deviation 0.693 | mm | |
| Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months | SMC021 Placebo | -0.40 | Standard Deviation 0.768 | mm | |
| Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index | SMC021 Oral Calcitonin | -80.6 | Standard Deviation 112.22 | Units on a scale | |
| Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index | SMC021 Placebo | -87.9 | Standard Deviation 116.25 | Units on a scale | |
| Bone & Cartilage Metabolism Biochemical Marker Change (Percentage). | SMC021 Oral Calcitonin | Serum CTX-I (ng/mL) | 50.6 | Standard Deviation 83.74 | percentage of change |
| Bone & Cartilage Metabolism Biochemical Marker Change (Percentage). | SMC021 Placebo | Serum CTX-I (ng/mL) | 40.6 | Standard Deviation 45.52 | percentage of change |
| Bone & Cartilage Metabolism Biochemical Marker Change (Percentage). | SMC021 Oral Calcitonin | Serum Osteocalcin (ng/mL) | 3.6 | Standard Deviation 37.42 | percentage of change |
| Bone & Cartilage Metabolism Biochemical Marker Change (Percentage). | SMC021 Placebo | Serum Osteocalcin (ng/mL) | 3.9 | Standard Deviation 26.32 | percentage of change |
| Bone & Cartilage Metabolism Biochemical Marker Change (Percentage). | SMC021 Oral Calcitonin | 24-h urine CTX-I/creatinine (µg/mmol) | 9.8 | Standard Deviation 85.95 | percentage of change |
| Bone & Cartilage Metabolism Biochemical Marker Change (Percentage). | SMC021 Placebo | 24-h urine CTX-I/creatinine (µg/mmol) | 7.2 | Standard Deviation 44.36 | percentage of change |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SMC021 Oral Calcitonin | 521 | |
| Overall Study | STARTED | SMC021 Placebo | 509 | |
| Overall Study | COMPLETED | SMC021 Oral Calcitonin | 300 | |
| Overall Study | COMPLETED | SMC021 Placebo | 339 | |
| Overall Study | NOT COMPLETED | SMC021 Oral Calcitonin | 221 | |
| Overall Study | NOT COMPLETED | SMC021 Placebo | 170 |
Source ClinicalTrials.gov
Adverse events324
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 | SMC021 Oral Calcitonin | 86 | 520 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | SMC021 Placebo | 111 | 508 | |
| other | Hot flush | Vascular disorders | SMC021 Oral Calcitonin | 88 | 520 | |
| other | Hot flush | Vascular disorders | SMC021 Placebo | 22 | 508 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | SMC021 Oral Calcitonin | 52 | 520 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | SMC021 Placebo | 54 | 508 | |
| other | Nausea | Gastrointestinal disorders | SMC021 Oral Calcitonin | 77 | 520 | |
| other | Nausea | Gastrointestinal disorders | SMC021 Placebo | 15 | 508 | |
| other | Influenza | Infections and infestations | SMC021 Oral Calcitonin | 46 | 520 | |
| other | Influenza | Infections and infestations | SMC021 Placebo | 40 | 508 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SMC021 Oral Calcitonin | ||
| Total, all-cause mortality | SMC021 Placebo | ||
| Total, other adverse events | SMC021 Oral Calcitonin | 474 | 520 |
| Total, other adverse events | SMC021 Placebo | 459 | 508 |
| Total, serious adverse events | SMC021 Oral Calcitonin | 77 | 520 |
| Total, serious adverse events | SMC021 Placebo | 80 | 508 |
Source ClinicalTrials.gov
Papers6
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 |
|---|
| SMC021 Oral Calcitonin vs SMC021 Placebo: 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00704847
GET https://conductscience.org/api/trials/v1/NCT00704847/results?page=2