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

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ClinicalTrials.gov Identifier: NCT00486434
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : June 28, 2012
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S

Tracking Information
First Submitted Date  ICMJE June 13, 2007
First Posted Date  ICMJE June 14, 2007
Results First Submitted Date  ICMJE March 28, 2012
Results First Posted Date  ICMJE June 28, 2012
Last Update Posted Date April 26, 2019
Study Start Date  ICMJE May 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 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.
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee [ 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 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).
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee. [ 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 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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2007)
JSW in the medial tibiofemoral knee joint in signal knee measured by X-ray after 12 & 24 months Pain to be assessed by WOMAC pain sub score in the signal knee Functional disability to be assessed by WOMAC function sub score in the signal knee
Change History Complete list of historical versions of study NCT00486434 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Changes in Biochemical Markers of Bone & Cartilage Metabolism. [ Time Frame: From Baseline to Month 24 ]
    The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done.
  • Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months [ Time Frame: Baseline and Month 24 ]
    To assess disease progression of OA affected joints, X-rays of both hands were performed & assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, & joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses. The AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated.
  • Nature and # of AEs Monitored Continuously During Study [ Time Frame: From Baseline to Month 24 ]
    Adverse events were by system organ class of all patients.
  • Disease Progression in the Knee Evaluated by MRI. [ Time Frame: From Baseline to Month 24 ]
    Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2007)
Changes in Biochemical Markers of Bone & Cartilage Metabolism.Effect on Hand OA Assessed by X-ray & Questionnaire at Baseline and After 24 Months.Disease Progression in the Knee Evaluated by MRI.Nature and # of AEs Monitored Continuously During Study
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
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: SMC021 Oral Calcitonin
    0.8mg SMC021 (Oral Calcitoinin) twice daily
  • Drug: SMC021 Placebo
    Placebo orally, twice daily
Study Arms  ICMJE
  • Active Comparator: 1
    SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months
    Intervention: Drug: SMC021 Oral Calcitonin
  • Placebo Comparator: 2
    SMC021 Placebo, orally twice daily during 24 months
    Intervention: Drug: SMC021 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 Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2012)
1176
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2007)
1150
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (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 Czechia,   Denmark,   Estonia,   Hong Kong,   Poland,   Romania
Removed Location Countries Czech Republic,   Lithuania
 
Administrative Information
NCT Number  ICMJE NCT00486434
Other Study ID Numbers  ICMJE CSMC021C2301
Has Data Monitoring Committee Not Provided
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 Chair: Bente J Riis, M.D. Nordic Bioscience A/S
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