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

April 3, 2019 updated by: Nordic Bioscience A/S

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1030

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Hospital Universitaire St. Luc, UCL 5390
  • Canada
      • Sainte-Foy (Québec), Canada, G1W 4R4
        • Centre de Rhumatologie St-Louis
  • Czechia
      • Pardubice, Czechia, 53002
        • CCBR Czech
  • Denmark
      • Aalborg, Denmark, 9000
        • CCBR Aalborg
      • Ballerup, Denmark, 2750
        • CCBR Ballerup
      • Vejle, Denmark, 7100
        • CCBR Vejle
  • Hong Kong
      • Hong Kong, Hong Kong
        • CCBR Hong Kong
  • Poland
      • Bialystok, Poland, 15-461
        • Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2
      • Warsaw, Poland, 04703
        • CCBR Poland
  • Romania
      • Bucharest, Romania, 030463
        • CCBR Romania
  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario de La Paz
  • United Kingdom
    • East Sussex
      • Bexhill-on-Sea, East Sussex, United Kingdom, TN 39 4SP
        • Little Common Surgery
  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35406
        • Achieve Clinical Research, LLC
    • California
      • Sacramento, California, United States, 95817
        • Center for Healthy Aging
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Center for Clinical Research
    • Missouri
      • Saint Peters, Missouri, United States, 63376
        • Midwest Pharmaceutical Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Thurston Arthritis Research Center
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Rheumatology Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
SMC021 Oral Calcitonin
Drug: Oral Salmon Calcitonin
0.8mg SMC021, twice daily
PLACEBO_COMPARATOR: 2
SMC021 Placebo
Drug: Oral Salmon Calcitonin (Placebo)
0.8mg Placebo, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
Change from baseline to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
Time Frame: From baseline to 24 months
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.
From baseline to 24 months
Knee Disease Progression Assessed by MRI
Time Frame: From baseline to month 12 and month 24
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.
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

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):

I. 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.
From baseline to months 1, 6, 12 and 24
Questionnaire to Assess Stiffness in the Signal Knee.
Time Frame: Baseline to month 24

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.
Baseline to month 24
Questionnaire to Assess Health-related Quality of Life
Time Frame: From baseline to month 24

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.
From baseline to month 24
Questionnaire to Assess Pain
Time Frame: Baseline, month 1, month 6, month 12, month 24
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.
Baseline, month 1, month 6, month 12, month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Bioscience A/S

Collaborators

Novartis

Investigators

  • Study Director: Bente Juel Riis, MD, Nordic Bioscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 24, 2008

First Posted (ESTIMATE)

June 25, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMC021C2302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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