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Trial · Interventional

TerminatedPhase 2Registry data

Effects of Oral Salmon Calcitonin in Human Osteoarthritis

Overview

Status
Terminated
Phase
Phase 2
Enrollment
54 participants
Sponsor
Université Catholique de Louvain · Other
Design
Randomized · Double masking
Countries
1 country

Belgium

Start
Sept 2002
Primary completion
Not stated
Completion
May 2004
First posted
14 Sept 2006 (estimated)
Last update posted
14 Sept 2006 (estimated)
Conditions
Osteoarthritis

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2002200320042005
  1. Ph 2

    Effects of Oral Salmon Calcitonin in Human Osteoarthritis

    NCT00376311

    Sept 2002 to May 2004

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • oral salmon calcitoninDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Lequesne's algofunctional index

  2. Biomarkers of joint metabolism

Secondary outcomes(1)
  1. Safety and tolerance

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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