Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis
Phase 1
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00486317
- Lead Sponsor
- Nordic Bioscience A/S
- Brief Summary
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin and 200 IU nasal calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Medical history and symptoms of knee osteoarthritis
Exclusion Criteria
- Any other disease or medication affecting the bone or cartilage.
- Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of adverse events
- Secondary Outcome Measures
Name Time Method Changes in Urine CTX-I and CTX-II Changes in serum osteocalcin
Trial Locations
- Locations (1)
CCBR A/S
🇩🇰Ballerup, Denmark