Pharmacokinetics and Pharmacodynamics Study of Oral Salmo... | NCT00411125

Studies
Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

NCT00411125

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 13, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Postmenopausal Osteoporosis

Interventions

Oral salmon calcitonin

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006

First Submitted Date

Dec 11, 2006

First Submission Date that Met QC Criteria

Dec 11, 2006

First Posted Date

Dec 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2006

Last Update Posted Date

Dec 13, 2006Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Oral salmon calcitonin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic profile of the new variant compared to the current variant on Day 1
Effect on bone resorption biomarker on Day 1

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy postmenopausal women

Exclusion Criteria:

Previous treatment with other osteoporosis medication

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Basel	Novartis Basel +41 61 324 1111	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19055791	Derived	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.

ID	Term
D015663	Osteoporosis, Postmenopausal
D010024	Osteoporosis

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases