Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
NCT ID: NCT00486434
Last Updated: 2019-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1176 participants
INTERVENTIONAL
2007-05-31
2010-09-30
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, 0.8 mg twice daily during 24 months
SMC021 Oral Calcitonin
0.8mg SMC021 (Oral Calcitoinin) twice daily
2
SMC021 Placebo, orally twice daily during 24 months
SMC021 Placebo
Placebo orally, twice daily
Interventions
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SMC021 Oral Calcitonin
0.8mg SMC021 (Oral Calcitoinin) twice daily
SMC021 Placebo
Placebo orally, 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 J Riis, M.D.
Role: STUDY_CHAIR
Nordic Bioscience A/S
Locations
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CCBR Czech
Pardubice, , Czechia
CCBR Aalborg
Aalborg, , Denmark
CCBR Ballerup
Ballerup Municipality, , Denmark
CCBR Vejle
Vejle, , Denmark
CCBR Estonia
Tallinn, , Estonia
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
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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CSMC021C2301
Identifier Type: -
Identifier Source: org_study_id
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