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Trial record 16 of 231 for:    CALCITONIN SALMON

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

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: SMC021 Oral Calcitonin Drug: SMC021 Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1176 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 : May 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: 1
SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months
Drug: SMC021 Oral Calcitonin
0.8mg SMC021 (Oral Calcitoinin) twice daily

Placebo Comparator: 2
SMC021 Placebo, orally twice daily during 24 months
Drug: SMC021 Placebo
Placebo orally, twice daily




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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.



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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): NCT00486434


Locations
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Czechia
CCBR Czech
Pardubice, Czechia, 53002
Denmark
CCBR Aalborg
Aalborg, Denmark, 9000
CCBR Ballerup
Ballerup, Denmark, 2750
CCBR Vejle
Vejle, Denmark, 7100
Estonia
CCBR Estonia
Tallinn, Estonia, 10128
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
Sponsors and Collaborators
Nordic Bioscience A/S
Novartis
Investigators
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Study Chair: Bente J Riis, M.D. Nordic Bioscience A/S

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: NCT00486434     History of Changes
Other Study ID Numbers: CSMC021C2301
First Posted: June 14, 2007    Key Record Dates
Results First Posted: June 28, 2012
Last Update Posted: April 26, 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