OsteoarthritisPhase 3NCT00704847

Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)

A Phase 3 study testing Oral Salmon Calcitonin in people with Osteoarthritis, run by Nordic Bioscience A/S at 18 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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?: Oral Salmon Calcitonin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,030 participants
Where: 18 sitesin 10 countries
Study dates: Jun 2008to Jun 2011
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

18 sites in 10 countries.

Country

City, postcode or hospital

18 sites in 10 countries

United States6 sites

Rheumatology Clinical Research Unit
Beachwood, Ohio, 44122
Thurston Arthritis Research Center
Chapel Hill, North Carolina, 27599
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, 63376
Center for Healthy Aging
Sacramento, California, 95817
Achieve Clinical Research, LLC
Tuscaloosa, Alabama, 35406

Other trials in United States

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

Belgium1 site

Hospital Universitaire St. Luc, UCL 5390
Brussels, 1200

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Canada1 site

Centre de Rhumatologie St-Louis
Sainte-Foy (Québec), G1W 4R4

Other trials in Canada

Czechia1 site

CCBR Czech
Pardubice, 53002

Other trials in Czechia

Hong Kong1 site

CCBR Hong Kong
Hong Kong

Other trials in Hong Kong

Romania1 site

CCBR Romania
Bucharest, 030463

Other trials in Romania

Spain1 site

Hospital Universitario de la Paz
Madrid, 28046

Other trials in Spain

United Kingdom1 site

Little Common Surgery
Bexhill-on-Sea, East Sussex, TN 39 4SP

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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: Oral Salmon Calcitonin, Oral Salmon Calcitonin (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.

Oral Salmon CalcitoninDrug
0.8mg SMC021, twice daily
Oral Salmon Calcitonin (Placebo)Drug
0.8mg Placebo, twice daily

Study groups in NCT00704847
Study group	Role	What they receive
1	Active comparator	SMC021 Oral Calcitonin Receives: Drug: Oral Salmon Calcitonin
2	Placebo comparator	SMC021 Placebo Receives: Drug: Oral Salmon Calcitonin (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 Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 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
Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index
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).
Measured: Change from baseline to 24 months

Secondary outcomes (6)

Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
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.
Measured: From baseline to 24 months
Knee Disease Progression Assessed by MRI
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.
Measured: From baseline to month 12 and month 24
Questionnaire to Assess Function and Physical Activity
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):
1. 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.
Measured: From baseline to months 1, 6, 12 and 24
Questionnaire to Assess Stiffness in the Signal Knee.
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.
Measured: Baseline to month 24
Questionnaire to Assess Health-related Quality of Life
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.
Measured: From baseline to month 24
Questionnaire to Assess Pain
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.
Measured: Baseline, month 1, month 6, month 12, month 24

Timeline

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

Jun 2008Jun 2011

First posted25 Jun 2008 (estimated)
Study startJun 2008
Primary completionMay 2011
Study completionJun 2011

Why it stopped: Male subjects were terminated due to an imbalance in prostate cancer events

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 (6)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: 1,030 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00704847
Sponsor's protocol ID: CSMC021C2302
Status last verified: Apr 2019
First submitted: 24 Jun 2008
Last updated: 24 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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?

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Study at a glance

From the registry record, last updated by the sponsor on 24 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: NCT00704847
Acronym / sponsor ID: CSMC021C2302
Conditions: Osteoarthritis
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy,, tolerability
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Male subjects were terminated due to an imbalance in prostate cancer events
Enrolment: 1,030 participants (actual)
Lead sponsor: Nordic Bioscience A/SIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: Jun 2008
Primary completion: May 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 25 Jun 2008 (estimated)
Results: Posted 12 Sep 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: Oral Salmon CalcitoninSMC021 Oral Calcitonin
2	Placebo comparator	Drug: Oral Salmon Calcitonin (Placebo)SMC021 Placebo

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
Oral Salmon Calcitonin0.8mg SMC021, twice daily	Drug	1
Oral Salmon Calcitonin (Placebo)0.8mg Placebo, twice daily	Drug	2

Primary outcome

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
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.
Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index
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 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).

6 secondary outcomes

Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
Time frame: From baseline to 24 months
Knee Disease Progression Assessed by MRI
Time frame: From baseline to month 12 and month 24
Questionnaire to Assess Function and Physical Activity
Time frame: From baseline to months 1, 6, 12 and 24
Questionnaire to Assess Stiffness in the Signal Knee.
Time frame: Baseline to month 24
Questionnaire to Assess Health-related Quality of Life
Time frame: From baseline to month 24
Questionnaire to Assess Pain
Time frame: Baseline, month 1, month 6, month 12, month 24

Results and safety

Results posted to the registry on 12 Sep 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
SMC021 Oral Calcitonin	521	300
SMC021 Placebo	509	339

Primary outcome: 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

Time frame: Change from baseline to 24 months. Mean (Standard Deviation). Unit: mm

Measure	SMC021 Oral Calcitonin n = 520	SMC021 Placebo n = 508
Value	-0.32 (0.693)	-0.40 (0.768)

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 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.

Primary outcome: Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index

Time frame: Change from baseline to 24 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	SMC021 Oral Calcitonin n = 520	SMC021 Placebo n = 508
Value	-80.6 (112.22)	-87.9 (116.25)

6 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
SMC021 Oral Calcitonin	77 of 520 (14.8%)	474 of 520 (91.2%)	Not reported
SMC021 Placebo	80 of 508 (15.7%)	459 of 508 (90.4%)	Not reported

Limitations and caveats (from the sponsor): The study showed an underexposure to calcitonin compared to what was expected from phase I trials.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Juel Riis, MD study director

Nordic Bioscience

18 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral Salmon Calcitonin in people with Osteoarthritis, run by Nordic Bioscience A/S at 18 sites in 10 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: stopped early, as of the sponsor's last update on 24 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 18 sites in United States, Denmark, Poland, Belgium, Canada and 5 more countries. 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 12 Sep 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 Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months (time frame: Change from baseline to 24 months). The study lists 2 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 NCT00704847, which also lists 6 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 24 Apr 2019.