Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

This study has been completed.

First Received on June 13, 2007. No Changes Posted

Sponsor:	Nordic Bioscience A/S
Collaborator:	Novartis
Information provided by:	Nordic Bioscience A/S
ClinicalTrials.gov Identifier:	NCT00486317

Purpose

The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin and 200 IU nasal calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.

Condition	Intervention	Phase
Osteoarthritis	Drug: Oral salmon calcitonin, salmon calcitonin nasal spray	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

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:

Number of adverse events

Secondary Outcome Measures:

Changes in Urine CTX-I and CTX-II
Changes in serum osteocalcin

Study Start Date:

October 2005

Eligibility

Ages Eligible for Study:	52 Years to 75 Years
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486317

Locations

Denmark
CCBR A/S
Ballerup, Denmark, 2750

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

ClinicalTrials.gov Identifier:	NCT00486317 History of Changes
Other Study ID Numbers:	SMC021A2110
Study First Received:	June 13, 2007
Last Updated:	June 13, 2007
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Nordic Bioscience A/S:

Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers

Additional relevant MeSH terms:

Osteoarthritis
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 12, 2012