Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis - Full Text View

Sponsor:	Nordic Bioscience A/S
Collaborator:	Novartis
Information provided by:	Nordic Bioscience A/S
ClinicalTrials.gov Identifier:	NCT00486434

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	Phase III

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: Osteoarthritis X-Rays

Drug Information available for: Calcitonin human Calcitonin Fortical

U.S. FDA Resources

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

Primary Outcome Measures:

JSW in the medial tibiofemoral knee joint in signal knee measured by X-ray after 12 & 24 months Pain to be assessed by WOMAC pain sub score in the signal knee Functional disability to be assessed by WOMAC function sub score in the signal knee [ Time Frame: January 2010 ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment:	1150
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/Placebo, twice daily
Placebo Comparator: 2 SMC021 Placebo	Drug: SMC021 Oral Calcitonin 0.8mg SMC021/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):

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. Epub 2010 Oct 11.

Responsible Party:	Bente Riis, Nordic Bioscience
ClinicalTrials.gov Identifier:	NCT00486434 History of Changes
Other Study ID Numbers:	CSMC021C2301
Study First Received:	June 13, 2007
Last Updated:	September 29, 2010
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

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 February 09, 2012