Turner SyndromePhase 4NCT00266656
Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
A Phase 4 study testing Humatrope in people with Turner Syndrome, run by Eli Lilly and Company at 9 sites in United States.
Trial summary
This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. Read more about this study
- Who is it for?
- Ages 4 to 20 years, women only
- Conditions the study is for
- Turner Syndrome
- What is being tested?
- Humatrope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2005to Sep 2015
- Phase
- Phase 4
- 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 4 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Previously randomized in study B9R-US-GDFG (NCT00406926)
- Karyotype-proven Turner syndrome
Who cannot join
- Immediate family members of study site personnel directly affiliated with the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Children's Hospital
Aurora, Colorado, 80045
University of NC at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27514
Children's Hospital of Chicago Research Center
Chicago, Illinois, 60611
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Riley Hosptial for Children
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Missouri, 64108
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Childrens Hospital and Medical Center
Seattle, Washington, 98105
About this study
Official title: Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome
This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.
- Conditions
- Turner Syndrome
- Being tested
- Humatrope
- Medical subject headings
- Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumatropeDrug
Also called LY137998, Somatropin, Growth hormone
According to investigator's clinical practice and guided by the approved package insert
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 Control | Experimental | No drug administration in B9R-US-GDFG (NCT00406926).
Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given. Receives: Drug: Humatrope |
| Experimental 2 Humatrope | Experimental | Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given. Receives: Drug: Humatrope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most Mature Height Standard Deviation Score (SDS)
SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Measured: Baseline through End of Study (10 years)
Secondary outcomes (8)
Height SDS at Various Ages
SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Measured: Age 10, Age 13, Age 16
Age at Attainment of Tanner 2 Breast Development
The Tanner 2 breast development is the age at first evidence of breast development.
Measured: Baseline through End of Study (10 years)
Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years
Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.
Measured: Baseline through End of Study (10 years)
Reports of Serious Adverse Events
Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria).
A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Measured: Baseline through End of Study (10 years)
Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events
Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.
Measured: Baseline through End of Study (10 years)
Percentage of Participants With Abnormal Tympanometry Results
Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint.
Measured: Baseline, Age 10, Age 16, End of Study (10 years)
Percentage of Participants With Prevalence of Abnormal Audiometry Results
Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.
Measured: Baseline, Age 10, Age 16, End of Study (10 years)
Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)
Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.
Measured: Baseline, Age 10, Age 16, End of Study (10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionSep 2015
- Study completionSep 2015
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 Turner SyndromeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hrs), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266656
- Sponsor's protocol ID
- 10088
- Other IDs
- B9R-US-GDGH
- Status last verified
- Mar 2017
- First submitted
- 15 Dec 2005
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome
- ClinicalTrials.gov ID
- NCT00266656
- Acronym / sponsor ID
- 10088
- Conditions
- Turner Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Dec 2005 (estimated)
- Results
- Posted 23 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 Control | Experimental | Drug: HumatropeNo drug administration in B9R-US-GDFG (NCT00406926). Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given. |
| Experimental 2 Humatrope | Experimental | Drug: HumatropeHumatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given. |
Who may qualify
- Ages
- 4 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Previously randomized in study B9R-US-GDFG (NCT00406926)
- Karyotype-proven Turner syndrome
Key exclusion criteria (1 listed)
- Immediate family members of study site personnel directly affiliated with the study
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 |
|---|---|---|
| HumatropeAlso: LY137998, Somatropin, Growth hormoneAccording to investigator's clinical practice and guided by the approved package insert | Drug | Experimental 1 Control, Experimental 2 Humatrope |
Primary outcome
Most Mature Height Standard Deviation Score (SDS)
Time frame: Baseline through End of Study (10 years)
SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
8 secondary outcomes
Height SDS at Various Ages
Time frame: Age 10, Age 13, Age 16
Age at Attainment of Tanner 2 Breast Development
Time frame: Baseline through End of Study (10 years)
Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years
Time frame: Baseline through End of Study (10 years)
Reports of Serious Adverse Events
Time frame: Baseline through End of Study (10 years)
Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events
Time frame: Baseline through End of Study (10 years)
Percentage of Participants With Abnormal Tympanometry Results
Time frame: Baseline, Age 10, Age 16, End of Study (10 years)
Percentage of Participants With Prevalence of Abnormal Audiometry Results
Time frame: Baseline, Age 10, Age 16, End of Study (10 years)
Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)
Time frame: Baseline, Age 10, Age 16, End of Study (10 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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 hrs) study director
Eli Lilly and Company
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Humatrope in people with Turner Syndrome, run by Eli Lilly and Company at 9 sites 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 2 inclusion and 1 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2016). 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?
Most Mature Height Standard Deviation Score (SDS) (time frame: Baseline through End of Study (10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2017.