NCT00395395

Brief Summary

This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
Last Updated

May 28, 2007

Status Verified

May 1, 2007

First QC Date

October 31, 2006

Last Update Submit

May 25, 2007

Conditions

Postmenopausal Osteoporosis

Keywords

PostmenopausalosteoporosisPharmacokinetics/dynamicsCalcitonin

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal

Secondary Outcomes (3)

  • Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal

  • PK profile of the carrier of oral salmon calcitonin, taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal

  • PK profile of salmon calcitonin nasal spray

Interventions

Oral salmon calcitonin, salmon calcitonin nasal sprayDRUG

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

Multiple Cities, Denmark

Location

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

October 31, 2006

First Posted

November 2, 2006

Study Start

October 1, 2006

Last Updated

May 28, 2007

Record last verified: 2007-05

Locations

DK(1)