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Trial record 13 of 231 for:    CALCITONIN SALMON

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

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ClinicalTrials.gov Identifier: NCT00704847
Recruitment Status : Terminated (Male subjects were terminated due to an imbalance in prostate cancer events)
First Posted : June 25, 2008
Results First Posted : September 12, 2012
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Oral Salmon Calcitonin Drug: Oral Salmon Calcitonin (Placebo) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1030 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.


  5. 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.


  6. 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.



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Ages Eligible for Study:   51 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704847


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nordic Bioscience A/S
ClinicalTrials.gov Identifier: NCT00704847     History of Changes
Other Study ID Numbers: CSMC021C2302
First Posted: June 25, 2008    Key Record Dates
Results First Posted: September 12, 2012
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by Nordic Bioscience A/S:
Osteoarthritis, oral salmon calcitonin, treatment, efficacy,
tolerability
Additional relevant MeSH terms:
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Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents