Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study) - Full Text View

Sponsors and Collaborators:	Nordic Bioscience A/S Novartis
Information provided by:	Nordic Bioscience A/S
ClinicalTrials.gov Identifier:	NCT00704847

Purpose

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	Intervention	Phase
Osteoarthritis	Drug: Oral Salmon Calcitonin Drug: Oral Salmon Calcitonin (Placebo)	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Calcitonin human Calcitonin Fortical

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Nordic Bioscience A/S:

Primary Outcome Measures:

• Joint Space Width in the medial tibio-femoral knee joint in the signal knee measured by X-ray change from baseline over 24 months • Pain to be assessed by the WOMAC pain sub score in the signal knee [ Time Frame: April 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Bone & Cartilage metabolism biochemical marker change • Questionnaires to assess function, stiffness, pain, physical activity, and quality of life •Knee disease progression assessed by MRI [ Time Frame: April 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	920
Study Start Date:	June 2008
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator SMC021 Oral Calcitonin	Drug: Oral Salmon Calcitonin 0.8mg SMC021, twice daily
2: Placebo Comparator SMC021 Placebo	Drug: Oral Salmon Calcitonin (Placebo) 0.8mg Placebo, twice daily

Eligibility

Ages Eligible for Study:	51 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704847

Locations

United States, Alabama
Achieve Clinical Research, LLC
Tuscaloosa, Alabama, United States, 35406
United States, California
Center for Healthy Aging
Sacramento, California, United States, 95817
United States, Illinois
Northwestern Center for Clinical Research
Chicago, Illinois, United States, 60611
United States, Missouri
Midwest Pharmaceutical Research
St. Peters, Missouri, United States, 63376
United States, North Carolina
Thurston Arthritis Research Center
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Rheumatology Clinical Research Unit
Beachwood, Ohio, United States, 44122
Belgium
Hospital Universitaire St. Luc, UCL 5390
Brussels, Belgium, 1200
Canada
Centre de Rhumatologie St-Louis
Sainte-Foy (Québec), Canada, G1W 4R4
Czech Republic
CCBR Czech
Pardubice, Czech Republic, 53002
Denmark
CCBR Aalborg
Aalborg, Denmark, 9000
CCBR Ballerup
Ballerup, Denmark, 2750
CCBR Vejle
Vejle, Denmark, 7100
Hong Kong
CCBR Hong Kong
Hong Kong, Hong Kong
Poland
CCBR Poland
Warsaw, Poland, 04703
Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2
Bialystok, Poland, 15-461
Romania
CCBR Romania
Bucharest, Romania, 030463
Spain
Hospital Universitario de la Paz
Madrid, Spain, 28046
United Kingdom
Little Common Surgery
East Sussex, United Kingdom, TN 39 4SP

Sponsors and Collaborators

Nordic Bioscience A/S

Novartis

Investigators

Study Director:

Bente Juul Riis, MD

Nordic Bioscience

More Information

No publications provided

Responsible Party:	Nordic Bioscience A/S ( Bente Juel Riis )
Study ID Numbers:	CSMC021C2302
Study First Received:	June 24, 2008
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00704847 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Hong Kong: Department of Health; Hong Kong: Ethics Committee; Turkey: Ethics Committee; Turkey: Ministry of Health; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee; Belgium: Directorate general for the protection of Public health: Medicines; Belgium: Institutional Review Board; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Spain: Spanish Agency of Medicines; Spain: Comité Ético de Investigación Clínica; Canada: Health Canada; Canada: Ethics Review Committee

Keywords provided by Nordic Bioscience A/S:

Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability

Study placed in the following topic categories:

Calcitonin Gene-Related Peptide
Calcitonin
Osteoarthritis, Knee
Vasodilator Agents
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Bone Density Conservation Agents
Cardiovascular Agents
Rheumatic Diseases
Salmon calcitonin

Additional relevant MeSH terms:

Calcitonin
Vasodilator Agents
Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Bone Density Conservation Agents
Cardiovascular Agents
Rheumatic Diseases

Salmon calcitonin
Pharmacologic Actions
Calcitonin Gene-Related Peptide
Osteoarthritis, Knee
Musculoskeletal Diseases
Therapeutic Uses
Arthritis

ClinicalTrials.gov processed this record on May 06, 2009