Clinical trial NCT00704847: Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy,
tolerability
Lead sponsor: Nordic Bioscience A/S
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2008-06-25
Enrollment: 1030
Sex: ALL
Minimum age (years): 51
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Change from baseline to 24 months
measure: Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index
timeFrame: Change from baseline to 24 months
Secondary outcomes:
measure: Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
timeFrame: From baseline to 24 months
measure: Knee Disease Progression Assessed by MRI
timeFrame: From baseline to month 12 and month 24
measure: Questionnaire to Assess Function and Physical Activity
timeFrame: From baseline to months 1, 6, 12 and 24
measure: Questionnaire to Assess Stiffness in the Signal Knee.
timeFrame: Baseline to month 24
measure: Questionnaire to Assess Health-related Quality of Life
timeFrame: From baseline to month 24
measure: Questionnaire to Assess Pain
timeFrame: Baseline, month 1, month 6, month 12, month 24
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Sacramento
country: United States
facility: Center for Healthy Aging
state: California
city: Chicago
country: United States
facility: Northwestern Center for Clinical Research
state: Illinois
city: Saint Peters
country: United States
facility: Midwest Pharmaceutical Research
state: Missouri
city: Chapel Hill
country: United States
facility: Thurston Arthritis Research Center
state: North Carolina
city: Beachwood
country: United States
facility: Rheumatology Clinical Research Unit
state: Ohio
city: Brussels
country: Belgium
facility: Hospital Universitaire St. Luc, UCL 5390
city: Sainte-Foy (Québec)
country: Canada
facility: Centre de Rhumatologie St-Louis
city: Pardubice
country: Czechia
facility: CCBR Czech
city: Aalborg
country: Denmark
facility: CCBR Aalborg
city: Ballerup
country: Denmark
facility: CCBR Ballerup
city: Vejle
country: Denmark
facility: CCBR Vejle
city: Hong Kong
country: Hong Kong
facility: CCBR Hong Kong
city: Bialystok
country: Poland
facility: Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2
city: Warsaw
country: Poland
facility: CCBR Poland
city: Bucharest
country: Romania
facility: CCBR Romania
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz
city: Bexhill-on-Sea
country: United Kingdom
facility: Little Common Surgery
state: East Sussex
Study officials:
affiliation: Nordic Bioscience
name: Bente Juel Riis, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.