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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-11-30

Brief Summary

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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

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Conditions

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Postmenopausal Osteoporosis

Keywords

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Postmenopausal osteoporosis Pharmacokinetics/dynamics Calcitonin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oral salmon calcitonin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy postmenopausal women

Exclusion Criteria

* Previous treatment with other osteoporosis medication

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Novartis Basel

Role: STUDY_DIRECTOR

Novartis Basel +41 61 324 1111

Locations

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Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED

PMID: 19055791 (View on PubMed)

Other Identifiers

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CSMC021A2111

Identifier Type: -

Identifier Source: org_study_id