A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects with Knee Osteoarthritis.

Conditions: This is a phase III trial.The population will be ambulatory men and women with knee osteoarthritis between 51 and 80 years old, in general good health.
MedDRA version: 9.1Level: LLTClassification code 10031161Term: Osteoarthritis

Registration Number: EUCTR2005-004145-34-DK

Lead Sponsor: ordic Bioscience A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1150

Inclusion Criteria

Ambulatory men and women with knee osteoarthritis, between 51 and 80 years old, in general good health.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Any disease or medication affecting the bone or cartilage metabolism (osteoporosis is allowed).
• Conditions causing secondary osteoarthritis of the study joint
• Obese study subjects with unilateral aggressive progressing knee OA.
• Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years.
• Any clinical signs or laboratory evidence for severe renal/liver/pulmonary, neurologic, cardiovascular, metabolic, hematological or psychiatric condition, which in the Investigator’s opinion would preclude the participant from adhering to the Protocol or completing the trial.
• Diagnostic arthroscopy with a surgical procedure within 6 moths prior to the screening or plan to have a surgery during the clinical trial.
• History of drug abuse or active alcoholism.
• Any investigational drug(s) within 30 days prior to screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this trial is to study the effect on joint space width (JSW) measured by X-ray, pain and functional disability assessed by the WOMAC Questionnaire of oral calcitonin treatment in subjects with osteoarthritis of the knee (OA).;Secondary Objective: JSW, pain and disability in the other knee<br>Hand Osteoarthritis<br>Safety;Primary end point(s): The aim of the trial is to study the effect of oral calcitonin compared to placebo with three primary endpoints: <br><br>1.JSW in the medial tibio-femoral knee joint in the signal knee measured by X-ray<br><br>2. Pain to be assesses by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain sub score in the signal knee<br><br>3. Functional disability to be assessed by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) function sub score in the signal knee.<br>

Secondary Outcome Measures