Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S
ClinicalTrials.gov Identifier:
NCT00486434
First received: June 13, 2007
Last updated: October 22, 2012
Last verified: October 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: SMC021 Oral Calcitonin
Drug: SMC021 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 Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 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 criterias. 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 criterias were met. The outcome was meassured as a change in JSW from baseline to month 24.

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee [ 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 function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolut change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee. [ 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 degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolut change from baseline to 24 months. If the outcome is less that 0 there is improvement (less diffulty).


Secondary Outcome Measures:
  • Changes in Biochemical Markers of Bone & Cartilage Metabolism.Effect on Hand OA Assessed by X-ray & Questionnaire at Baseline and After 24 Months.Disease Progression in the Knee Evaluated by MRI.Nature and # of AEs Monitored Continuously During Study [ Time Frame: January 2010 ] [ Designated as safety issue: No ]

Enrollment: 1176
Study Start Date: May 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
SMC021 Oral Calcitonin
Drug: SMC021 Oral Calcitonin
0.8mg SMC021 twice daily
Placebo Comparator: 2
SMC021 Placebo
Drug: SMC021 Placebo
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: NCT00486434

Locations
Czech Republic
CCBR Czech
Pardubice, Czech Republic, 53002
Denmark
CCBR Aalborg
Aalborg, Denmark, 9000
CCBR Ballerup
Ballerup, Denmark, 2750
CCBR Vejle
Vejle, Denmark, 7100
Estonia
CCBR Estonia
Tallinn, Estonia, 10128
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
Sponsors and Collaborators
Nordic Bioscience A/S
Novartis
Investigators
Study Chair: Bente J Riis, M.D. Nordic Bioscience A/S
  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: NCT00486434     History of Changes
Other Study ID Numbers: CSMC021C2301
Study First Received: June 13, 2007
Results First Received: March 28, 2012
Last Updated: October 22, 2012
Health Authority: Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control
Romania: National Medicines Agency
Hong Kong: Department of Health
United States: Food and Drug Administration

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 April 15, 2014