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

NCT00704847 | Terminated Phase 3 Results DMC

• 1 other identifier: CSMC021C2302
• Study Type: interventional
• Target: 1,030
• Locations: 10 countries
• Sites: 18

Brief 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

Conditions

Osteoarthritis

Keywords

Osteoarthritis, oral salmon calcitonin, treatment, efficacy,; tolerability

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Change from baseline to 24 months

Secondary Outcomes (6)

• Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).

  From baseline to 24 months

• Knee Disease Progression Assessed by MRI

  From baseline to month 12 and month 24

• Questionnaire to Assess Function and Physical Activity

  From baseline to months 1, 6, 12 and 24

• Questionnaire to Assess Stiffness in the Signal Knee.

  Baseline to month 24

• Questionnaire to Assess Health-related Quality of Life

  From baseline to month 24

Study Arms (2)

1

ACTIVE COMPARATOR

SMC021 Oral Calcitonin

Drug: Oral Salmon Calcitonin

2

PLACEBO COMPARATOR

SMC021 Placebo

Drug: Oral Salmon Calcitonin (Placebo)

Interventions

Oral Salmon Calcitonin DRUG

0.8mg SMC021, twice daily

1

Oral Salmon Calcitonin (Placebo) DRUG

0.8mg Placebo, twice daily

2

Eligibility Criteria

• Age: 51 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical history and symptoms of knee osteoarthritis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordic Bioscience A/S: lead
• Novartis: collaborator

Study Sites (18)

Achieve Clinical Research, LLC

Tuscaloosa, Alabama, 35406, United States

Location

Center for Healthy Aging

Sacramento, California, 95817, United States

Location

Northwestern Center for Clinical Research

Chicago, Illinois, 60611, United States

Location

Midwest Pharmaceutical Research

City of Saint Peters, Missouri, 63376, United States

Location

Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

Location

Rheumatology Clinical Research Unit

Beachwood, Ohio, 44122, United States

Location

Hospital Universitaire St. Luc, UCL 5390

Brussels, 1200, Belgium

Location

Centre de Rhumatologie St-Louis

Sainte-Foy (Québec), G1W 4R4, Canada

Location

CCBR Czech

Pardubice, 53002, Czechia

Location

CCBR Aalborg

Aalborg, 9000, Denmark

Location

CCBR Ballerup

Ballerup Municipality, 2750, Denmark

Location

CCBR Vejle

Vejle, 7100, Denmark

Location

CCBR Hong Kong

Hong Kong, Hong Kong

Location

Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2

Bialystok, 15-461, Poland

Location

CCBR Poland

Warsaw, 04703, Poland

Location

CCBR Romania

Bucharest, 030463, Romania

Location

Hospital Universitario de la Paz

Madrid, 28046, Spain

Location

Little Common Surgery

Bexhill-on-Sea, East Sussex, TN 39 4SP, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 32249039 DERIVED

• 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.

  PMID: 31481084 DERIVED

• 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.

  PMID: 29343266 DERIVED

• 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.

  PMID: 25582279 DERIVED

• 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.

  PMID: 20932224 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

salmon calcitonin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

The study showed an underexposure to calcitonin compared to what was expected from phase I trials.

Results Point of Contact

• Title: Bente Juel Riis, Medical Director
• Organization: Nordic Bioscience A/S

bjr@nordicbioscience.com

+45 22901317

Study Officials

• Bente Juel Riis, MD

  Nordic Bioscience

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 25, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 24, 2019
• Results First Posted: September 12, 2012

Record last verified: 2019-04

Locations

BE (1); CA (1); US (6); GB (1); PL (2); DK (3); RO (1); HK (1); ES (1); CZ (1)