Effects of Oral Salmon Calcitonin in Human Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis

Keywords

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Lequesne's algo-functional score Biomarkers of joint metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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oral salmon calcitonin

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Daniel H Manicourt, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Daniel H Manicourt

Identifier Type: -

Identifier Source: org_study_id