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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01078805
First received: March 1, 2010
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention
Osteoporosis
Drug: FORTEO

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Direct Assessment of Non-Vertebral Fractures in Community Experience (DANCE)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants With Non-Vertebral Fragility Fractures [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Clinical Vertebral Fractures [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    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%.

  • Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    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%.

  • Treatment Adherence [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.

  • Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint [ Time Frame: Baseline, up to month 24 ] [ Designated as safety issue: No ]
    A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).

  • Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint [ Time Frame: Baseline, up to month 24 ] [ Designated as safety issue: No ]
    BMC is an estimate of the amount of mineral (such as calcium) in the bone.

  • Percentage Change From Baseline in Bone Area at Month 24 Endpoint [ Time Frame: Baseline, up to month 24 ] [ Designated as safety issue: No ]
    Bone area is a defined region of interest of bone.

  • Physician Criteria for Initiating FORTEO Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 4167
Study Start Date: August 2003
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
FORTEO (teriparatide)-treated
FORTEO-treated
Drug: FORTEO
prescribed in accordance with usual clinical practice for up to 24 months
Other Names:
  • FORTEO
  • Teriparatide
  • LY333334

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078805

Locations
United States, Colorado
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01078805     History of Changes
Other Study ID Numbers: 8492, B3D-US-GHCQ
Study First Received: March 1, 2010
Results First Received: January 30, 2012
Last Updated: May 16, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014