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Trial · Observational

CompletedPhase not statedResults postedRegistry data

Study of FORTEO Use in Subjects in the Community Setting

Short name DANCE

NCTNCT01078805 (opens ClinicalTrials.gov in a new tab)Other id8492Other idB3D-US-GHCQ
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
4,167 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Not stated
Countries
1 country

United States

Start
Aug 2003
Primary completion
Feb 2011
Completion
Feb 2011
First posted
2 Mar 2010 (estimated)
Last update posted
26 Jun 2012 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042006200820102012
  1. Ph –

    DANCE

    NCT01078805

    Aug 2003 to Feb 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • FORTEODrug

Arms1

  • Other

    FORTEO (teriparatide)-treated

    FORTEO-treated

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With Non-Vertebral Fragility Fractures

    Time frame · up to 24 months

    Registry description

    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(8)

  1. Percentage of Participants With Clinical Vertebral Fractures

    Time frame · up to 24 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Bone area is a defined region of interest of bone.

  8. Physician Criteria for Initiating FORTEO Therapy

    Time frame · Baseline

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· up to 24 months

Percentage of Participants With Non-Vertebral Fragility Fractures

GroupValue (Percentage of participants)
FORTEO (Teriparatide)-Treated1.42
Secondary and other outcome results(7)
Secondary outcomeNumber· up to 24 months

Percentage of Participants With Clinical Vertebral Fractures

GroupValue (Percentage of participants)
FORTEO (Teriparatide)-Treated0.67
Secondary outcomeMean· Baseline, Month 24

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

GroupValue (percentage change of pain score)Spread
FORTEO (Teriparatide)-Treated-36.22.8
Secondary outcomeMean· Baseline, Month 24

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

GroupValue (percentage change of pain score)Spread
FORTEO (Teriparatide)-Treated-24.92.2
Secondary outcomeMean· up to 24 months

Treatment Adherence

GroupValue (days)Spread
FORTEO (Teriparatide)-Treated72.554.5
Secondary outcomeMean· Baseline, up to month 24

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

GroupValue (percentage (%) change of BMD)Spread
FORTEO (Teriparatide)-Treated2.5690.944
Secondary outcomeMean· Baseline, up to month 24

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

GroupValue (percentage (%) change of grams (g))Spread
FORTEO (Teriparatide)-Treated4.1871.707
Secondary outcomeMean· Baseline, up to month 24

Percentage Change From Baseline in Bone Area at Month 24 Endpoint

GroupValue (percent change of centimeter square)Spread
FORTEO (Teriparatide)-Treated2.2311.336

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
FORTEO (Teriparatide)-TreatedFORTEO: prescribed in accordance with usual clinical practice for up to 24 months–432 / 40850 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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