Study of FORTEO Use in Subjects in the Community Setting

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of FORTEO in a larger, more diverse "real world" population than studied in clinical trials

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Detailed Description

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Subjects will be followed through a course of FORTEO therapy for up to 24 months and for an additional 24 months after FORTEO treatment is stopped. Subjects may participate in this study for up to 48 months. All aspects of patient care, including diagnostic and therapeutic interventions, will be chosen and conducted at the discretion of the participating study physician according to their clinical judgment and the local standard of medical care.

Conditions

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Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FORTEO (teriparatide)-treated

FORTEO-treated

FORTEO

Intervention Type DRUG

prescribed in accordance with usual clinical practice for up to 24 months

Interventions

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FORTEO

prescribed in accordance with usual clinical practice for up to 24 months

Intervention Type DRUG

Other Intervention Names

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Teriparatide LY333334

Eligibility Criteria

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Inclusion Criteria

* Men and women who are judged by the study physician to be suitable for FORTEO therapy. The FORTEO product labeling specifies those individuals diagnosed with osteoporosis who are considered to be at high risk for fracture

Exclusion Criteria

* Subjects who have an increased baseline risk for osteosarcoma. These include Paget's disease of bone, pediatric populations and young adult patients with open epiphyses, prior external beam or implant radiation therapy involving the skeleton
* Subjects who have administered FORTEO or PTH therapy for more than two weeks directly before study entry
* Subjects who have completed a course of FORTEO or PTH therapy of at least 18 months duration before study entry

Eligible Sex

ALL

Accepts Healthy Volunteers

No