Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women

NCT ID: NCT00239889

Last Updated: 2006-11-30

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

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Brief Summary

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Calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.

Detailed Description

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Conditions

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Forearm Fracture

Keywords

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Forearm fracture Postmenopausal women Pain Grip strength Salmon calcitonin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Salmon calcitonin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal women, aged at least 60 years old
* Having a forearm fracture within the last 3-7 days before treatment
* Fracture is treated with either a plaster cast only, or a cast plus Kirschner wires

Exclusion Criteria

* Multiple fractures, severe fractures, or the forearm fractured in more than one place
* Nerve damage in the forearm caused by the fracture
* Other conditions which would interfere with the grip strength measurements (e.g. swelling, paralysis, skin diseases or rheumatoid arthritis)
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Basel 41 61 324 1111

Role: STUDY_CHAIR

Novartis

Locations

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Novartis

Nuremberg, , Germany

Site Status

Novartis

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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CSMC051A2402

Identifier Type: -

Identifier Source: org_study_id