NCT00376311

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2005

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
Last Updated

September 14, 2006

Status Verified

June 1, 2002

First QC Date

December 30, 2005

Last Update Submit

September 13, 2006

Conditions

Osteoarthritis

Keywords

Lequesne's algo-functional scoreBiomarkers of joint metabolism

Outcome Measures

Primary Outcomes (2)

  • Lequesne's algofunctional index

  • Biomarkers of joint metabolism

Secondary Outcomes (1)

  • Safety and tolerance

Interventions

oral salmon calcitoninDRUG

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Brussels, B-1200, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

salmon calcitonin

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Daniel H Manicourt, MD, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2005

First Posted

September 14, 2006

Study Start

September 1, 2002

Study Completion

May 1, 2004

Last Updated

September 14, 2006

Record last verified: 2002-06

Locations

BE(1)