Study of FORTEO Use in Subjects in the Community Setting

Osteoporosis Clinical Trial

— DANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078805
• Other study ID #: 8492
• Secondary ID: B3D-US-GHCQ
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: May 16, 2012
• Start date: August 2003
• Est. completion date: February 2011

Study information

• Verified date: May 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4167
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• FORTEO
prescribed in accordance with usual clinical practice for up to 24 months

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Non-Vertebral Fragility Fractures	Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk * 100.	up to 24 months	No
Secondary	Percentage of Participants With Clinical Vertebral Fractures	Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk * 100.	up to 24 months	No
Secondary	Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint	Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.	Baseline, Month 24	No
Secondary	Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint	Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.	Baseline, Month 24	No
Secondary	Treatment Adherence	Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.	up to 24 months	No
Secondary	Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint	A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).	Baseline, up to month 24	No
Secondary	Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint	BMC is an estimate of the amount of mineral (such as calcium) in the bone.	Baseline, up to month 24	No
Secondary	Percentage Change From Baseline in Bone Area at Month 24 Endpoint	Bone area is a defined region of interest of bone.	Baseline, up to month 24	No
Secondary	Physician Criteria for Initiating FORTEO Therapy	Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here.	Baseline	No