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Completed

NCT Number: NCT00486369

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

52 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CCBR A/S

Ballerup Municipality, 2750, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral salmon calcitonin

Drug

Secondary outcomes

  1. Changes in Urine CTX-I and CTX-II

  2. Changes in serum osteocalcin and serum CTX-I

  3. Number of adverse events

Sponsors and collaborators

Lead sponsor

Nordic Bioscience A/S

Industry

Collaborators

  • Novartis

Registry information

Official study title

SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.

Important dates

Study start
2007
First posted
Jun 14, 2007
Registry last updated
Jun 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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