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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Somatropin Treatment to Final Height in Turner Syndrome

Short name GDCT

NCTNCT00191113 (opens ClinicalTrials.gov in a new tab)Other id817/4419Other id#817 B9R-CA-GDCT Core studyOther id#4419 GDCT/1 Addenda
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Overview

Status
Completed
Phase
Phase 3
Enrollment
154 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
Feb 1989
Primary completion
Dec 2007
Completion
Dec 2007
First posted
19 Sept 2005 (estimated)
Last update posted
27 Jan 2010 (estimated)
Conditions
Turner Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1990199520002005
  1. Ph 3

    GDCT

    NCT00191113

    Feb 1989 to Dec 2007

Registry summary

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

A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.

Interventions

  • SomatropinDrug
  • Ethinyl estradiolDrug
  • Medroxyprogesterone acetateDrug

Arms2

  • No intervention

    Control

    Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).

  • Experimental

    Humatrope

    Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population

    Time frame · Baseline, and end of 4-year addendum

    Registry description

    Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.

  2. Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height

    Time frame · at completion of core study, or at end of 4-year addendum

    Registry description

    SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS \[NCHS\] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS \[Lyon\] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS \[NCHS\] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.

Secondary outcomes(16)

  1. Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population

    Time frame · every 3 months during core study, and at start and end of 4-year addendum

    Registry description

    Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.

  2. Height (Centimeters [cm])

    Time frame · every 3 months during core study, and at start and end of 4-year addendum

    Registry description

    Most mature measurement available, at or after attainment of Final Height.

  3. Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment

    Time frame · at completion of core study or beginning of addendum

  4. Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment

    Time frame · at completion of core study or beginning of addendum

  5. Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment

    Time frame · at completion of core study or beginning of addendum

  6. Number of Participants With Hearing Loss, Audiologist Assessment

    Time frame · at completion of core study or beginning of addendum

    Registry description

    Sensorineural Hearing Loss (SNHL)=air conduction threshold \>20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold \>20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap \>10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present.

  7. Fasting Glucose, Change From Baseline

    Time frame · At core study baseline, and at end of 4-year addendum

    Registry description

    Change from core study baseline to addendum 2 maximum.

  8. Maximum Fasting Glucose Value

    Time frame · At start and through end of 4-year addendum (up to an additional 2 years)

    Registry description

    Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

  9. Number of Participants With Any Abnormal Fasting Glucose Value

    Time frame · At start and through end of 4-year addendum

    Registry description

    Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose \>=100 milligrams per deciliter (mg/dL).

  10. Maximum Fasting Insulin Values

    Time frame · At start and through end of 4-year addendum (up to an additional 2 years)

    Registry description

    Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

  11. Number of Participants With Any Abnormal Fasting Insulin Value

    Time frame · At start and through end of 4-year addendum

    Registry description

    Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin \>=35 micro International Units per milliliter (uIU/mL).

  12. Minimum Fasting Glucose/Insulin Ratio Values

    Time frame · At start and through end of 4-year addendum (up to an additional 2 years)

    Registry description

    Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years.

  13. Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value

    Time frame · At start and through end of 4-year addendum

    Registry description

    Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio \<=4.5 milligrams per 10\^-4 Units (mg/10\^-4U).

  14. Glycosylated Hemoglobin, Change From Baseline

    Time frame · At core study baseline, and at end of 4-year addendum

    Registry description

    Change from core study baseline to addendum 2 maximum.

  15. Maximum Glycosylated Hemoglobin

    Time frame · At start and through end of 4-year addendum (up to an additional 2 years)

    Registry description

    Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

  16. Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value

    Time frame · At start and through end of 4-year addendum

    Registry description

    Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards).

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 outcomeLeast squares mean· Baseline, and end of 4-year addendum

Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population

GroupValue (Standard Deviation Score (SDS) [NCHS])Spread
As-Randomized Control0.090.07
As-Randomized Humatrope0.970.07
Primary outcomeLeast squares mean· at completion of core study, or at end of 4-year addendum

Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height

GroupValue (Standard Deviation Score (SDS) [NCHS])Spread
As-Treated No Growth Hormone-3.300.07
As-Treated Growth Hormone-2.250.05
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· every 3 months during core study, and at start and end of 4-year addendum

Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population

GroupValue (Standard Deviation Score (SDS) [NCHS])Spread
As-Treated No Growth Hormone-0.090.08
As-Treated Growth Humatrope0.990.06
Secondary outcomeLeast squares mean· every 3 months during core study, and at start and end of 4-year addendum

Height (Centimeters [cm])

GroupValue (centimeters (cm))Spread
As-Treated No Growth Hormone141.630.47
As-Treated Growth Humatrope148.520.36
Secondary outcomeNumber· at completion of core study or beginning of addendum

Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment

GroupValue (participants)
As-Treated No Growth Hormone10
As-Treated Growth Hormone29
Secondary outcomeNumber· at completion of core study or beginning of addendum

Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment

GroupValue (participants)
As-Treated No Growth Hormone3
As-Treated Growth Hormone12
Secondary outcomeNumber· at completion of core study or beginning of addendum

Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment

GroupValue (participants)
As-Treated No Growth Hormone2
As-Treated Growth Hormone18
Secondary outcomeNumber· at completion of core study or beginning of addendum

Number of Participants With Hearing Loss, Audiologist Assessment

GroupValue (participants)
As-Treated No Growth Hormone1
As-Treated Growth Hormone7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Treated-As-Randomized ControlPatients in the As-Randomized Control group who at each observed time point remained untreated with growth hormone.–10 / 5453 / 54
Treated-As-Randomized HumatropePatients in the As-Randomized Humatrope group who received Humatrope–22 / 7474 / 74

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2011

Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone.

Taback et al. 2011BMC pediatricscited by 23

PMID 21619701PMC3125334DOI 10.1186/1471-2431-11-49PUB-21619701

CC BY
Download PDF

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultHamelin CE, Anglin G, Quigley CA, Deal CL. Genomic imprinting in Turner syndrome: effects on response to growth hormone and on risk of sensorineural hearing loss. J Clin Endocrinol Metab. 2006 Aug;91(8):3002-10. doi: 10.1210/jc.2006-0490. Epub 2006 Jun 6. PMID 16757526
  • ResultStephure DK; Canadian Growth Hormone Advisory Committee. Impact of growth hormone supplementation on adult height in turner syndrome: results of the Canadian randomized controlled trial. J Clin Endocrinol Metab. 2005 Jun;90(6):3360-6. doi: 10.1210/jc.2004-2187. Epub 2005 Mar 22. PMID 15784709

Eligibility

Who could join, as posted.

Sex
Female
Age
from 7 Years up to 13 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * girl with Turner syndrome * prepubertal, Tanner stage I breast * height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population * at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity * if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests Exclusion Criteria: * prior treatment with growth hormone * presence of a Y component in karyotype with gonads in situ * diabetes mellitus

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