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Study of FORTEO Use in Subjects in the Community Setting

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: FORTEO (Drug)

Phase: N/A

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Summary

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

Clinical Details

Official title: Direct Assessment of Non-Vertebral Fractures in Community Experience (DANCE)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Percentage of Participants With Non-Vertebral Fragility Fractures

Secondary outcome:

Percentage of Participants With Clinical Vertebral Fractures

Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint

Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint

Treatment Adherence

Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint

Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint

Percentage Change From Baseline in Bone Area at Month 24 Endpoint

Physician Criteria for Initiating FORTEO Therapy

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lakewood, Colorado, United States
Additional Information

Starting date: August 2003
Last updated: May 16, 2012

Page last updated: August 20, 2015

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