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

NCT00486434 | Completed Phase 3 Results

• 1 other identifier: CSMC021C2301
• Study Type: interventional
• Target: 1,176
• Locations: 6 countries
• Sites: 9

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 (3)

• 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.

  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).

  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).

  Change from baseline to 24 months

Secondary Outcomes (4)

• Changes in Biochemical Markers of Bone & Cartilage Metabolism.

  From Baseline to Month 24

• Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months

  Baseline and Month 24

• Nature and # of AEs Monitored Continuously During Study

  From Baseline to Month 24

• Disease Progression in the Knee Evaluated by MRI.

  From Baseline to Month 24

Study Arms (2)

1

ACTIVE COMPARATOR

SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months

Drug: SMC021 Oral Calcitonin

2

PLACEBO COMPARATOR

SMC021 Placebo, orally twice daily during 24 months

Drug: SMC021 Placebo

Interventions

SMC021 Oral Calcitonin DRUG

0.8mg SMC021 (Oral Calcitoinin) twice daily

1

SMC021 Placebo DRUG

Placebo orally, 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 (9)

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 Estonia

Tallinn, 10128, Estonia

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

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

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

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

bjr@nordicbioscience.com

+4522901317

Study Officials

• Bente J Riis, M.D.

  Nordic Bioscience A/S

  STUDY CHAIR

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 13, 2007
• First Posted: June 14, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 26, 2019
• Results First Posted: June 28, 2012

Record last verified: 2019-04

Locations

PL (2); CZ (1); DK (3); HK (1); ES (1); RO (1)