- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00486369
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study
June 13, 2007 updated by: Nordic Bioscience A/S
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.
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.
Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) 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.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ballerup, Denmark, 2750
- CCBR A/S
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
52 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Secondary Outcome Measures
Outcome Measure |
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Number of adverse events
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Changes in Urine CTX-I and CTX-II
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Changes in serum osteocalcin and serum CTX-I
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Bente J Riis, M.D., Nordic Bioscience A/S
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Karsdal MA, Byrjalsen I, Bay-Jensen AC, Henriksen K, Riis BJ, Christiansen C. Biochemical markers identify influences on bone and cartilage degradation in osteoarthritis--the effect of sex, Kellgren-Lawrence (KL) score, body mass index (BMI), oral salmon calcitonin (sCT) treatment and diurnal variation. BMC Musculoskelet Disord. 2010 Jun 17;11:125. doi: 10.1186/1471-2474-11-125.
- Karsdal MA, Byrjalsen I, Henriksen K, Riis BJ, Lau EM, Arnold M, Christiansen C. The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study. Osteoarthritis Cartilage. 2010 Feb;18(2):150-9. doi: 10.1016/j.joca.2009.08.004. Epub 2009 Sep 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Registration Dates
First Submitted
June 13, 2007
First Submitted That Met QC Criteria
June 13, 2007
First Posted (Estimate)
June 14, 2007
Study Record Updates
Last Update Posted (Estimate)
June 14, 2007
Last Update Submitted That Met QC Criteria
June 13, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSMC021C2102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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