OsteoarthritisPhase 3NCT00486434

Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis

A Phase 3 study testing SMC021 Oral Calcitonin in people with Osteoarthritis, run by Nordic Bioscience A/S at 9 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 51 to 80 years
Conditions the study is for: Osteoarthritis
What is being tested?: SMC021 Oral Calcitonin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,176 participants
Where: 9 sitesin 6 countries
Study dates: May 2007to Sep 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 51 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Medical history and symptoms of knee osteoarthritis

Who cannot join

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

Trial locations and contacts

9 sites in 6 countries.

Country

City, postcode or hospital

9 sites in 6 countries

Denmark3 sites

CCBR Aalborg
Aalborg, 9000
CCBR Ballerup
Ballerup Municipality, 2750
CCBR Vejle
Vejle, 7100

Other trials in Denmark

Poland2 sites

Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2
Bialystok, 15-461
CCBR Poland
Warsaw, 04703

Other trials in Poland

Czechia1 site

CCBR Czech
Pardubice, 53002

Other trials in Czechia

Estonia1 site

CCBR Estonia
Tallinn, 10128

Other trials in Estonia

Hong Kong1 site

CCBR Hong Kong
Hong Kong

Other trials in Hong Kong

Romania1 site

CCBR Romania
Bucharest, 030463

Other trials in Romania

About this study

Official title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis

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.

Conditions: Osteoarthritis
Being tested: SMC021 Oral Calcitonin, SMC021 Placebo
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SMC021 Oral CalcitoninDrug
0.8mg SMC021 (Oral Calcitoinin) twice daily
SMC021 PlaceboDrug
Placebo orally, twice daily

Study groups in NCT00486434
Study group	Role	What they receive
1	Active comparator	SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months Receives: Drug: SMC021 Oral Calcitonin
2	Placebo comparator	SMC021 Placebo, orally twice daily during 24 months Receives: Drug: SMC021 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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).
Measured: Change from baseline to 24 months

Secondary outcomes (4)

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.
Measured: From Baseline to Month 24
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.
Measured: Baseline and Month 24
Nature and # of AEs Monitored Continuously During Study
Adverse events were by system organ class of all patients.
Measured: 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.
Measured: From Baseline to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Sep 2010

First posted14 Jun 2007 (estimated)
Study startMay 2007
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00486434
Sponsor's protocol ID: CSMC021C2301
Status last verified: Apr 2019
First submitted: 13 Jun 2007
Last updated: 26 Apr 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 42092979
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.
PubMed 41764561
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.
PubMed 32249039
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.
PubMed 31481084
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.
PubMed 29343266
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.
PubMed 25582279
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.
PubMed 20932224

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT00486434
Acronym / sponsor ID: CSMC021C2301
Conditions: Osteoarthritis
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,176 participants (actual)
Lead sponsor: Nordic Bioscience A/SIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: May 2007
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 14 Jun 2007 (estimated)
Results: Posted 28 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: SMC021 Oral CalcitoninSMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months
2	Placebo comparator	Drug: SMC021 PlaceboSMC021 Placebo, orally twice daily during 24 months

Who may qualify

Ages: 51 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Medical history and symptoms of knee osteoarthritis

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SMC021 Oral Calcitonin0.8mg SMC021 (Oral Calcitoinin) twice daily	Drug	1
SMC021 PlaceboPlacebo orally, twice daily	Drug	2

Primary outcome

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
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
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
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).

4 secondary outcomes

Changes in Biochemical Markers of Bone & Cartilage Metabolism.
Time frame: From Baseline to Month 24
Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
Time frame: Baseline and Month 24
Nature and # of AEs Monitored Continuously During Study
Time frame: From Baseline to Month 24
Disease Progression in the Knee Evaluated by MRI.
Time frame: From Baseline to Month 24

Results and safety

Results posted to the registry on 28 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Arm	588	394
Placebo Arm	588	454

Primary outcome: 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. Mean (Standard Deviation). Unit: mm

Measure	Active Arm n = 585	Placebo Arm n = 584
Value	-0.188 (0.5626)	-0.198 (0.5069)

Population analysed: 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.

Primary outcome: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee

Time frame: Change from baseline to 24 months. Median (Inter-Quartile Range). Unit: Units on a scale

Measure	Active Arm n = 585	Placebo Arm n = 584
Value	-124.0 (-391 to 218)	-109.0 (-410 to 349)

Primary outcome: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.

Time frame: Change from baseline to 24 months. Median (Inter-Quartile Range). Unit: Units on a scale

Measure	Active Arm n = 585	Placebo Arm n = 584
Value	-390.0 (-1307 to 783)	-299.5 (-1342 to 915)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline until 30 days following the end of study.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Arm	100 of 585 (17.1%)	548 of 585 (93.7%)	Not reported
Placebo Arm	88 of 584 (15.1%)	520 of 584 (89%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42092979Hannani 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.
Derived from this study: PubMed 41764561Bay-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.
Derived from this study: PubMed 32249039Bihlet 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.
Derived from this study: PubMed 31481084Bihlet 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.
Derived from this study: PubMed 29343266Bihlet 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.
Derived from this study: PubMed 25582279Karsdal 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.
Derived from this study: PubMed 20932224Henriksen 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bente J Riis, M.D. study chair

Nordic Bioscience A/S

9 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SMC021 Oral Calcitonin in people with Osteoarthritis, run by Nordic Bioscience A/S at 9 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Denmark, Poland, Czechia, Estonia, Hong Kong and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00486434, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.