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

This study has been terminated.
(Male subjects were terminated due to an imbalance in prostate cancer events)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S
ClinicalTrials.gov Identifier:
NCT00704847
First received: June 24, 2008
Last updated: October 22, 2012
Last verified: September 2012
  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:


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

ClinicalTrials.gov processed this record on July 29, 2014