Study of FORTEO Use in Subjects in the Community Setting

An observational study of Osteoporosis, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Osteoporosis
What is being tested?: FORTEO
How many people: 4,167 participants
Where: 1 siteUnited States
Study dates: Aug 2003to Feb 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Community sample

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Osteoporosis
Being tested: FORTEO
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FORTEODrug
Also called Teriparatide, LY333334
prescribed in accordance with usual clinical practice for up to 24 months

Study groups in NCT01078805
Study group	Role	What they receive
FORTEO (teriparatide)-treated		FORTEO-treated Receives: Drug: FORTEO

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 24 months

Secondary outcomes (8)

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.
Measured: up to 24 months
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%.
Measured: Baseline, Month 24
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%.
Measured: Baseline, Month 24
Treatment Adherence
Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.
Measured: up to 24 months
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).
Measured: Baseline, up to month 24
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.
Measured: Baseline, up to month 24
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Bone area is a defined region of interest of bone.
Measured: Baseline, up to month 24
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.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2003Feb 2011

First posted2 Mar 2010 (estimated)
Study startAug 2003
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4,167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01078805
Sponsor's protocol ID: 8492
Other IDs: B3D-US-GHCQ
Acronym: DANCE
Status last verified: May 2012
First submitted: 1 Mar 2010
Last updated: 26 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Direct Assessment of Non-Vertebral Fractures in Community Experience (DANCE)
ClinicalTrials.gov ID: NCT01078805
Acronym / sponsor ID: DANCE / 8492
Conditions: Osteoporosis
Study type: Observational
Recruitment status: Completed
Enrolment: 4,167 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2003
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 2 Mar 2010 (estimated)
Results: Posted 26 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
FORTEO (teriparatide)-treated	–	Drug: FORTEOFORTEO-treated

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Community sample

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FORTEOAlso: Teriparatide, LY333334prescribed in accordance with usual clinical practice for up to 24 months	Drug	FORTEO (teriparatide)-treated

Primary outcome

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.

8 secondary outcomes

Percentage of Participants With Clinical Vertebral Fractures
Time frame: up to 24 months
Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint
Time frame: Baseline, Month 24
Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint
Time frame: Baseline, Month 24
Treatment Adherence
Time frame: up to 24 months
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
Time frame: Baseline, up to month 24
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
Time frame: Baseline, up to month 24
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Time frame: Baseline, up to month 24
Physician Criteria for Initiating FORTEO Therapy
Time frame: Baseline

Results and safety

Results posted to the registry on 26 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FORTEO (Teriparatide)-Treated	4,167	2,117

Primary outcome: Percentage of Participants With Non-Vertebral Fragility Fractures

Time frame: up to 24 months. Number. Unit: Percentage of participants

Measure	FORTEO (Teriparatide)-Treated n = 3720
0 to 6 months (n=3720)	1.42
6 to 12 months (n=2970)	0.91
12 to 18 months (n=2570)	0.70
18 to 24 months (n=2225)	0.81

FORTEO (Teriparatide)-Treated: p = 0.0177, One-sample binomial proportion test
FORTEO (Teriparatide)-Treated: p = 0.0019, One-sample binomial proportion test
FORTEO (Teriparatide)-Treated: p = 0.0143, One-sample binomial proportion test

Population analysed: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FORTEO (Teriparatide)-Treated	432 of 4,085 (10.6%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
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Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoporosis, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Non-Vertebral Fragility Fractures (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01078805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.