Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 8:52 PM
Study NCT ID:
NCT01078805
Status:
COMPLETED
Last Update Posted:
2012-06-26
First Post:
2010-03-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of FORTEO Use in Subjects in the Community Setting
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
Direct Assessment of Non-Vertebral Fractures in Community Experience (DANCE)
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DANCE
Brief 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
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| B3D-US-GHCQ | OTHER | Eli Lilly and Company | View |