NCT00486369

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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2007

Completed
Last Updated

June 14, 2007

Status Verified

June 1, 2007

First QC Date

June 13, 2007

Last Update Submit

June 13, 2007

Conditions

Osteoarthritis

Keywords

Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers

Outcome Measures

Secondary Outcomes (3)

  • Changes in Urine CTX-I and CTX-II

  • Changes in serum osteocalcin and serum CTX-I

  • Number of adverse events

Interventions

Oral salmon calcitoninDRUG

Eligibility Criteria

Age52 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical history and symptoms of knee osteoarthritis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CCBR A/S

Ballerup Municipality, 2750, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 20565725DERIVED

  • 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.

    PMID: 19747581DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

salmon calcitonin

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Bente J Riis, M.D.

    Nordic Bioscience A/S

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 13, 2007

First Posted

June 14, 2007

Study Start

January 1, 2007

Last Updated

June 14, 2007

Record last verified: 2007-06

Locations

DK(1)