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 III

MedlinePlus related topics:

Osteoarthritis

ChemIDplus related topics:

Calcitonin Calcitonin human 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: January 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: January 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

Contacts


Contact: Bente J Riis, M.D	+45 2290 1317	bjr@nordicbioscience.com

Show 25 Study Locations

Sponsors and Collaborators

Nordic Bioscience A/S

Novartis

More Information

Responsible Party:	Nordic Bioscience A/S ( Bente Juel Riis )
Study ID Numbers:	CSMC021C2302
First Received:	June 24, 2008
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00704847
Health Authority:	United States: Food and Drug Administration; Also The Health Authorities and Ethical Committees for the following countries:; Denmark, Brazil, Czech Republic, Poland, Romania, Hong Kong, Turkey, England, Belgium, France, Spain and Canada

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

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

Salmon calcitonin

Additional relevant MeSH terms:

Vasodilator Agents

Therapeutic Uses

Physiological Effects of Drugs

Bone Density Conservation Agents

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

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