Study of FORTEO Use in Subjects in the Community Setting (DANCE)

Lilly

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: FORTEO

Study type: Observational

Funder types: Industry

Identifiers

NCT01078805

B3D-US-GHCQ (Other Identifier)

8492

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,167 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

4,167 participants in 1 patient group

FORTEO (teriparatide)-treated

Description:

FORTEO-treated

Treatment:

Drug: FORTEO