Clinical trial NCT01078805: Study of FORTEO Use in Subjects in the Community Setting
Official title: Direct Assessment of Non-Vertebral Fractures in Community Experience (DANCE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 4167
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Non-Vertebral Fragility Fractures
timeFrame: up to 24 months
Secondary outcomes:
measure: Percentage of Participants With Clinical Vertebral Fractures
timeFrame: up to 24 months
measure: Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint
timeFrame: Baseline, Month 24
measure: Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint
timeFrame: Baseline, Month 24
measure: Treatment Adherence
timeFrame: up to 24 months
measure: Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
timeFrame: Baseline, up to month 24
measure: Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
timeFrame: Baseline, up to month 24
measure: Percentage Change From Baseline in Bone Area at Month 24 Endpoint
timeFrame: Baseline, up to month 24
measure: Physician Criteria for Initiating FORTEO Therapy
timeFrame: Baseline
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: 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.
state: Colorado
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: