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Trial record 13 of 235 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

Tracking Information
First Submitted Date  ICMJE June 24, 2008
First Posted Date  ICMJE June 25, 2008
Results First Submitted Date  ICMJE August 13, 2012
Results First Posted Date  ICMJE September 12, 2012
Last Update Posted Date April 24, 2019
Study Start Date  ICMJE June 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2008)
• Joint Space Width in the medial tibio-femoral knee joint in the signal knee measured by X-ray change from baseline over 24 months • Pain to be assessed by the WOMAC pain sub score in the signal knee [ Time Frame: January 2011 ]
Change History Complete list of historical versions of study NCT00704847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2008)
• Bone & Cartilage metabolism biochemical marker change • Questionnaires to assess function, stiffness, pain, physical activity, and quality of life •Knee disease progression assessed by MRI [ Time Frame: January 2011 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Oral Salmon Calcitonin
    0.8mg SMC021, twice daily
  • Drug: Oral Salmon Calcitonin (Placebo)
    0.8mg Placebo, twice daily
Study Arms  ICMJE
  • Active Comparator: 1
    SMC021 Oral Calcitonin
    Intervention: Drug: Oral Salmon Calcitonin
  • Placebo Comparator: 2
    SMC021 Placebo
    Intervention: Drug: Oral Salmon Calcitonin (Placebo)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 13, 2012)
1030
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2008)
920
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 51 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Denmark,   Hong Kong,   Poland,   Romania,   Spain,   United Kingdom,   United States
Removed Location Countries Brazil,   Czech Republic,   France,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT00704847
Other Study ID Numbers  ICMJE CSMC021C2302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nordic Bioscience A/S
Study Sponsor  ICMJE Nordic Bioscience A/S
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Director: Bente Juel Riis, MD Nordic Bioscience
PRS Account Nordic Bioscience A/S
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP