Skip to content

Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT00486369 (opens ClinicalTrials.gov in a new tab)Other idCSMC021C2102
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
Not stated
Sponsor
Nordic Bioscience A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
Jan 2007
Primary completion
Not stated
Completion
Not stated
First posted
14 Jun 2007 (estimated)
Last update posted
14 Jun 2007 (estimated)
Conditions
Osteoarthritis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008
  1. Ph 1

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

    NCT00486369

    Start Jan 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oral salmon calcitoninDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Secondary outcomes(3)

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

  2. Changes in serum osteocalcin and serum CTX-I

  3. Number of adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2010

7 results

The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study.

Karsdal et al. 2010Osteoarthritis and cartilagecited by 83

PMID 19747581DOI 10.1016/j.joca.2009.08.004PUB-19747581

Rights unknown7 results
Source linkSee results (7)

Indexing hint: Randomized controlled trial · 2010

1 result

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.

Karsdal et al. 2010BMC musculoskeletal disorderscited by 55

PMID 20565725PMC2902412DOI 10.1186/1471-2474-11-125PUB-20565725

CC BY1 result
Download PDFSee results (1)

Eligibility

Who could join, as posted.

Sex
All
Age
from 52 Years up to 75 Years
Healthy volunteers
Not stated
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.