Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)
NCT ID: NCT00704847
Last Updated: 2019-04-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1030 participants
INTERVENTIONAL
2008-06-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
SMC021 Oral Calcitonin
Oral Salmon Calcitonin
0.8mg SMC021, twice daily
2
SMC021 Placebo
Oral Salmon Calcitonin (Placebo)
0.8mg Placebo, twice daily
Interventions
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Oral Salmon Calcitonin
0.8mg SMC021, twice daily
Oral Salmon Calcitonin (Placebo)
0.8mg Placebo, twice daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
51 Years
80 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Nordic Bioscience A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Bente Juel Riis, MD
Role: STUDY_DIRECTOR
Nordic Bioscience
Locations
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Achieve Clinical Research, LLC
Tuscaloosa, Alabama, United States
Center for Healthy Aging
Sacramento, California, United States
Northwestern Center for Clinical Research
Chicago, Illinois, United States
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, United States
Thurston Arthritis Research Center
Chapel Hill, North Carolina, United States
Rheumatology Clinical Research Unit
Beachwood, Ohio, United States
Hospital Universitaire St. Luc, UCL 5390
Brussels, , Belgium
Centre de Rhumatologie St-Louis
Sainte-Foy (Québec), , Canada
CCBR Czech
Pardubice, , Czechia
CCBR Aalborg
Aalborg, , Denmark
CCBR Ballerup
Ballerup Municipality, , Denmark
CCBR Vejle
Vejle, , Denmark
CCBR Hong Kong
Hong Kong, , Hong Kong
Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2
Bialystok, , Poland
CCBR Poland
Warsaw, , Poland
CCBR Romania
Bucharest, , Romania
Hospital Universitario de la Paz
Madrid, , Spain
Little Common Surgery
Bexhill-on-Sea, East Sussex, United Kingdom
Countries
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References
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Bihlet AR, Bjerre-Bastos JJ, Andersen JR, Byrjalsen I, Karsdal MA, Bay-Jensen AC. Clinical and biochemical factors associated with risk of total joint replacement and radiographic progression in osteoarthritis: Data from two phase III clinical trials. Semin Arthritis Rheum. 2020 Dec;50(6):1374-1381. doi: 10.1016/j.semarthrit.2020.03.002. Epub 2020 Mar 15.
Bihlet AR, Byrjalsen I, Bay-Jensen AC, Andersen JR, Christiansen C, Riis BJ, Karsdal MA. Associations between biomarkers of bone and cartilage turnover, gender, pain categories and radiographic severity in knee osteoarthritis. Arthritis Res Ther. 2019 Sep 3;21(1):203. doi: 10.1186/s13075-019-1987-7.
Bihlet AR, Byrjalsen I, Bay-Jensen AC, Andersen JR, Christiansen C, Riis BJ, Valter I, Karsdal MA, Hochberg MC. Identification of pain categories associated with change in pain in patients receiving placebo: data from two phase 3 randomized clinical trials in symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2018 Jan 17;19(1):17. doi: 10.1186/s12891-018-1938-5.
Karsdal MA, Byrjalsen I, Alexandersen P, Bihlet A, Andersen JR, Riis BJ, Bay-Jensen AC, Christiansen C; CSMC021C2301/2 investigators. Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials. Osteoarthritis Cartilage. 2015 Apr;23(4):532-43. doi: 10.1016/j.joca.2014.12.019. Epub 2015 Jan 9.
Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11.
Other Identifiers
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CSMC021C2302
Identifier Type: -
Identifier Source: org_study_id
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