Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. This process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. It also will study what these areas look like after therapy is stopped.

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Osteoporosis

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teriparatide

Participants receive teriparatide 20 microgram once daily by subcutaneous injection for 18 months followed by 6 months off therapy

Group Type EXPERIMENTAL

teriparatide

Intervention Type DRUG

Subcutaneous, 20 microgram (mcg)/day, 18 months

Interventions

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teriparatide

Subcutaneous, 20 microgram (mcg)/day, 18 months

Intervention Type DRUG

Other Intervention Names

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LY333334 Forteo Forsteo

Eligibility Criteria

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Inclusion Criteria

* Ambulatory with osteoporosis
* Hip or spine bone mineral density (BMD) measurement more than 2.5 standard deviations below the average bone mass of young healthy women or more than 2.0 standard deviations in women who have a history of a vertebral or nonvertebral fragility fracture.

Exclusion Criteria

* Diseases of bone other than osteoporosis
* Treatment with estrogens in the 3 months prior to enrollment or for more than 2 months in the past year
* Treatment with oral bisphosphonates in the 3 months prior to enrollment or for more than 2 months in the past year; treatment with intravenous bisphosphonates in the 12 months prior to enrollment
* Increased risk for the development of osteosarcoma

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No