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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Arthritis Osteoarthritis

Drug Information available for: Calcitonin Salmon calcitonin

U.S. FDA Resources

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

Primary Outcome Measures:

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 [ Time Frame: Change from baseline to 24 months ] [ Designated as safety issue: No ]
The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index [ Time Frame: Change from baseline to 24 months ] [ Designated as safety issue: No ]
WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).

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: From baseline to 24 months ] [ Designated as safety issue: No ]


Enrollment:	1030
Study Start Date:	June 2008
Study Completion Date:	June 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2
Bialystok, Poland, 15-461
CCBR Poland
Warsaw, Poland, 04703
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 Juel Riis, MD	Nordic Bioscience

More Information

No publications provided by Nordic Bioscience A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.


Responsible Party:	Nordic Bioscience A/S
ClinicalTrials.gov Identifier:	NCT00704847 History of Changes
Other Study ID Numbers:	CSMC021C2302
Study First Received:	June 24, 2008
Results First Received:	August 13, 2012
Last Updated:	October 22, 2012
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: Federal Agency for Medicines and Health Products, FAMHP Belgium: Institutional Review Board France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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

Additional relevant MeSH terms:


Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Calcitonin Calcitonin Gene-Related Peptide	Salmon calcitonin Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on March 03, 2015