Clinical trial NCT00486434: Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
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: COMPLETED
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: 2007-06-14
Enrollment: 1176
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 Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.
timeFrame: Change from baseline to 24 months
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee
timeFrame: Change from baseline to 24 months
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.
timeFrame: Change from baseline to 24 months
Secondary outcomes:
measure: Changes in Biochemical Markers of Bone & Cartilage Metabolism.
timeFrame: From Baseline to Month 24
measure: Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
timeFrame: Baseline and Month 24
measure: Nature and # of AEs Monitored Continuously During Study
timeFrame: From Baseline to Month 24
measure: Disease Progression in the Knee Evaluated by MRI.
timeFrame: From Baseline to Month 24
Other outcomes:
Locations:
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: Tallinn
country: Estonia
facility: CCBR Estonia
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
Study officials:
affiliation: Nordic Bioscience A/S
name: Bente J Riis, M.D.
role: STUDY_CHAIR
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.