Primary outcomeMean· Change from baseline to 24 months
Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.
| Group | Value (mm) | Spread |
|---|---|---|
| Active Arm | -0.188 | 0.5626 |
| Placebo Arm | -0.198 | 0.5069 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
NCTNCT00486434 (opens ClinicalTrials.gov in a new tab)Other idCSMC021C2301
This trial does not test a peptide that PepBank tracks.
- Names Calcitonin-salmon, does not test it. It appears in the title.
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 1,176 participants (actual)
- Sponsor
- Nordic Bioscience A/S · Industry
- Design
- Randomized · Double masking
- Countries
6 countries
Czechia, Denmark, Estonia, Hong Kong, Poland, Romania
- Start
- May 2007
- Primary completion
- Sept 2010
- Completion
- Sept 2010
- First posted
- 14 Jun 2007 (estimated)
- Last update posted
- 26 Apr 2019
- Conditions
- Osteoarthritis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20072008200920102011
- Ph 3
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
NCT00486434May 2007 to Sept 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SMC021 Oral CalcitoninDrug
- SMC021 PlaceboDrug
Arms2
Active comparator
1
SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months
Placebo comparator
2
SMC021 Placebo, orally twice daily during 24 months
Primary outcomes3
Outcomes the sponsor listed as primary.
Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.
Time frame · Change from baseline to 24 months
Registry description
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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee
Time frame · Change from baseline to 24 months
Registry description
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).
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.
Time frame · Change from baseline to 24 months
Registry description
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 outcomes(4)
Changes in Biochemical Markers of Bone & Cartilage Metabolism.
Time frame · From Baseline to Month 24
Registry description
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.
Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
Time frame · Baseline and Month 24
Registry description
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.
Nature and # of AEs Monitored Continuously During Study
Time frame · From Baseline to Month 24
Registry description
Adverse events were by system organ class of all patients.
Disease Progression in the Knee Evaluated by MRI.
Time frame · From Baseline to Month 24
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMedian· Change from baseline to 24 months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee
| Group | Value (Units on a scale) |
|---|---|
| Active Arm | -124.0 |
| Placebo Arm | -109.0 |
Primary outcomeMedian· Change from baseline to 24 months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.
| Group | Value (Units on a scale) |
|---|---|
| Active Arm | -390.0 |
| Placebo Arm | -299.5 |
Secondary and other outcome results(4)
Secondary outcomeMean· From Baseline to Month 24
Changes in Biochemical Markers of Bone & Cartilage Metabolism.
| Group | Value (percentage of change) | Spread |
|---|---|---|
| Active Arm | 41.358 | 68.1153 |
| Placebo Arm | 62.883 | 65.7225 |
Secondary outcomeMean· Baseline and Month 24
Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| Active Arm | 0.40 | 0.784 |
| Placebo Arm | 0.40 | 0.754 |
Secondary outcomeNumber· From Baseline to Month 24
Nature and # of AEs Monitored Continuously During Study
| Group | Value (Number of AEs by system organ class) |
|---|---|
| Active Arm | 548 |
| Placebo Arm | 520 |
| Total | 1068 |
Secondary outcomeMean· From Baseline to Month 24
Disease Progression in the Knee Evaluated by MRI.
| Group | Value (percentage of change) | Spread |
|---|---|---|
| Active Arm | 2.90 | 10.104 |
| Placebo Arm | 0.26 | 9.283 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Active Arm0.8mg SMC021 Oral Calcitonin tablet twice daily | – | 100 / 585 | 548 / 585 |
| Placebo Arm1 SMC021 Placebo tablet twice daily | – | 88 / 584 | 520 / 584 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies3
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2015
3 results
Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials.
Karsdal et al. 2015Osteoarthritis and cartilagecited by 109
PMID 25582279DOI 10.1016/j.joca.2014.12.019PUB-25582279
Full text at the publisher3 results
More studies
2 studies on this page
PubMed tag: none · 2026
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.
Bay-Jensen et al. 2026BMC rheumatology
PMID 41764561PMC13059256DOI 10.1186/s41927-026-00628-wPUB-41764561
Free to read · publisher termsCC BY-NC-ND
PubMed tag: none · 2026
Therapeutic subtypes of knee osteoarthritis: differential treatment effects among predicted endotypes in past clinical trials.
Hannani et al. 2026Arthritis research & therapy
PMID 42092979PMC13317274DOI 10.1186/s13075-026-03825-7PUB-42092979
CC BY
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedBihlet 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. PMID 32249039
- DerivedBihlet 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. PMID 31481084
- DerivedBihlet 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. PMID 29343266
- DerivedHenriksen 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. PMID 20932224
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 51 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
PepBank is a research reference. Talk to a doctor before you use any peptide.