NCT00411125

Brief Summary

This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
Last Updated

December 13, 2006

Status Verified

December 1, 2006

First QC Date

December 11, 2006

Last Update Submit

December 11, 2006

Conditions

Postmenopausal Osteoporosis

Keywords

PostmenopausalosteoporosisPharmacokinetics/dynamicsCalcitonin

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic profile of the new variant compared to the current variant on Day 1

  • Effect on bone resorption biomarker on Day 1

Secondary Outcomes (3)

  • Effect on bone resorption biomarker 24 hours after the last dosing on Day 3

  • Effect on bone resorption biomarker after drug intake at different timepoints

  • Effect of dosing at different timepoints on the pharmacokinetic profile

Interventions

Oral salmon calcitoninDRUG

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy postmenopausal women

You may not qualify if:

  • Previous treatment with other osteoporosis medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Copenhagen, Denmark

Location

Related Publications (1)

  • Karsdal MA, Byrjalsen I, Riis BJ, Christiansen C. Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin. BMC Clin Pharmacol. 2008 Dec 4;8:12. doi: 10.1186/1472-6904-8-12.

    PMID: 19055791DERIVED

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

salmon calcitonin

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Novartis Basel

    Novartis Basel +41 61 324 1111

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 13, 2006

Study Start

August 1, 2006

Study Completion

November 1, 2006

Last Updated

December 13, 2006

Record last verified: 2006-12

Locations

DK(1)