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
- OsteoarthritisMedDRA version: 9.1Level: LLTClassification code 10031161Term: Osteoarthritis
- Registration Number
- EUCTR2007-003016-60-CZ
- Lead Sponsor
- ordic Bioscience A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 920
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
• 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-rays of the knee. ;Secondary Objective: Pain and functional disability assessed by the WOMAC Questionnaire <br>Safety;Primary end point(s): Joint Space Width (JSW) in the medial tibio-femoral knee joint in the signal knee measured by X-ray
- Secondary Outcome Measures
Name Time Method