Expired Study
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Sacramento, California 95817


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


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


Study is Available At:


Original ID:

CSMC021C2302


NCT ID:

NCT00704847


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

51 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nordic Bioscience A/S


Oversight 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


Reasons Why Stopped:

Male subjects were terminated due to an imba


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1030


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bente Juel Riis, MD
Study Director
Nordic Bioscience

Study Dates

Start Date:June 2008
Completion Date:June 2011
Completion Type:Actual
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 3, 2019
First Received Date:June 24, 2008
First Results Date:August 13, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Questionnaire to Assess Pain
Time Frame:Baseline, month 1, month 6, month 12, month 24
Safety Issues:False
Description:Pain was assessed by the WOMAC subscore in the signal knee by visit. Patients assessed their current pain level using a 100 mm visual analogue scales (VAS) by placing an X on the line that best describes his/her pain, where 0 equaled "No Pain" and 100 equ
Outcome Type:Secondary Outcome
Measure:Questionnaire to Assess Health-related Quality of Life
Time Frame:From baseline to month 24
Safety Issues:False
Description:Health-related quality of life was assessed by the EQ-5D questionnaire, which is a patient questionnaire for measure of health, developed by the EuroQol Group.The EQ-5D questionnaire was administered to patients in order to measure change in health-relate
Outcome Type:Secondary Outcome
Measure:Questionnaire to Assess Stiffness in the Signal Knee.
Time Frame:Baseline to month 24
Safety Issues:False
Description:WOMAC's stiffness subscore was used to assess the stiffness in the signal knee. 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
Outcome Type:Secondary Outcome
Measure:Questionnaire to Assess Function and Physical Activity
Time Frame:From baseline to months 1, 6, 12 and 24
Safety Issues:False
Description:Function and physical activity were assessed by assessed by WOMAC function sub-score in the signal knee. The criteria for assessment of the functional classification according to the American Rheumatism Association (ARA) were as follows (Hochberg et al 19
Outcome Type:Secondary Outcome
Measure:Knee Disease Progression Assessed by MRI
Time Frame:From baseline to month 12 and month 24
Safety Issues:False
Description:Knee cartilage volume and thickness was assessed by MRI in patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The sam
Outcome Type:Secondary Outcome
Measure:Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
Time Frame:From baseline to 24 months
Safety Issues:False
Description:The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX I/creatinine and CTX-II/creatinine. These biomarkers were analysed in order to assess the cartilage and bone turonver ratio to baseline at month 24.
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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 progres

Study Interventions

Intervention Type:Drug
Name:Oral Salmon Calcitonin
Description:0.8mg SMC021, twice daily
Arm Name:1
Intervention Type:Drug
Name:Oral Salmon Calcitonin (Placebo)
Description:0.8mg Placebo, twice daily
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:SMC021 Oral Calcitonin
Study Arm Type:Placebo Comparator
Arm Name:2
Description:SMC021 Placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Nordic Bioscience A/S
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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