A Study for Patients With Osteoporosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis

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Osteoporosis

UNKNOWN

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Teriparatide

Intervention Type DRUG

Subcutaneous, 20 micrograms/day, 24 weeks

B

Group Type ACTIVE_COMPARATOR

Salmon Calcitonin

Intervention Type DRUG

Intranasal, 200 International Units (IU)/day, 24 weeks

Interventions

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Teriparatide

Subcutaneous, 20 micrograms/day, 24 weeks

Intervention Type DRUG

Salmon Calcitonin

Intranasal, 200 International Units (IU)/day, 24 weeks

Intervention Type DRUG

Other Intervention Names

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LY333334 Forteo Forsteo

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of osteoporosis
* No other severe disabling conditions
* Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5
* Ambulatory
* Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)

Exclusion Criteria

* History of a disease that affects bone metabolism
* History of treatment with any drug that may significantly affect bone metabolism
* History or presence of liver disease
* History or presence of kidney disease
* History of excessive alcohol drinking or drug abuse

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No