Effects of Oral Salmon Calcitonin in Human Osteoarthritis - Full Text View

Sponsors and Collaborators:	Université Catholique de Louvain Novartis
Information provided by:	Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00376311

Purpose

To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis

Condition	Intervention	Phase
Osteoarthritis	Drug: oral salmon calcitonin	Phase II

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Calcitonin Calcitonin human Fortical

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis

Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:

Lequesne's algofunctional index
Biomarkers of joint metabolism

Secondary Outcome Measures:

Safety and tolerance

Estimated Enrollment:	54
Study Start Date:	September 2002
Estimated Study Completion Date:	May 2004

Detailed Description:

Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability.

Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.

Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

radiographic OA according to the criteria of the American College of Rheumatology;
morning joint stiffness between 15 and 30 minutes;
pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale;
normal liver and kidney function tests;
serum CRP levels < 10 mg/l

Exclusion Criteria:

previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene
crystal deposition diseases
known hereditary or congenital defects
clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases
intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376311

Locations

Belgium
St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain
Brussels, Belgium, B-1200

Sponsors and Collaborators

Université Catholique de Louvain

Novartis

Investigators

Study Director:

Daniel H Manicourt, MD, PhD

Department of Rheumatology, University hospital St Luc, Brussels, Belgium

More Information

Study ID Numbers:	Daniel H Manicourt
Study First Received:	December 30, 2005
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00376311
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Université Catholique de Louvain:

Lequesne's algo-functional score
Biomarkers of joint metabolism

Study placed in the following topic categories:

Calcitonin Gene-Related Peptide
Calcitonin
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 January 15, 2009