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OpenTrials
Completed

NCT Number: NCT01078805

Study of FORTEO Use in Subjects in the Community Setting

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forteo

Drug

prescribed in accordance with usual clinical practice for up to 24 months

Other names: Teriparatide, LY333334

Primary outcomes

  1. Percentage of Participants With Non-Vertebral Fragility Fractures

    Time frame: up to 24 months

    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 outcomes

  1. Percentage of Participants With Clinical Vertebral Fractures

    Time frame: up to 24 months

    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.

  2. Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint

    Time frame: Baseline, Month 24

    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%.

  3. Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint

    Time frame: Baseline, Month 24

    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%.

  4. Treatment Adherence

    Time frame: up to 24 months

    Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.

  5. Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint

    Time frame: Baseline, up to month 24

    A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).

  6. Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint

    Time frame: Baseline, up to month 24

    BMC is an estimate of the amount of mineral (such as calcium) in the bone.

  7. Percentage Change From Baseline in Bone Area at Month 24 Endpoint

    Time frame: Baseline, up to month 24

    Bone area is a defined region of interest of bone.

  8. Physician Criteria for Initiating FORTEO Therapy

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: DANCE

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2010
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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