Growth DisordersPhase 3NCT06103513
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
A Phase 3 study testing Somatropin in people with Growth Disorders and Growth Failure, run by Northwell Health at 1 site in United States.
Trial summary
A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Disorders, Growth Failure, Growth Hormone Treatment
- What is being tested?
- Somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2023to 5 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 5-15 years
- In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
- Ability to take subcutaneous GH injections nightly
Who cannot join
- Subjects will be excluded if they have GH resistance, or syndromic short stature such as Prader Willi syndrome and Turner syndrome. Patients will also be excluded if they have active malignancies, or systemic illnesses such as heart failure, kidney failure, or liver failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwell Health
New York, New York, 11042
Neetu Vashistha, MA, 516-472-3631, nvashistha@northwell.edu
Ishrat Ghani, 516-472-3631, ighani@northwell.edu
About this study
Official title: A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment
A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
Read the detailed description
Investigators propose a prospective randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years. 25 subjects will be randomized to initiate a dose of 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week (0.18-0.22 mg/kg/week) for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
- Conditions
- Growth Disorders, Growth Failure, Growth Hormone Treatment, Growth
- Being tested
- Somatropin
- Keywords
- Growth Hormone
- Medical subject headings
- Growth Disorders, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Also called Norditropin, Nutropin AQ, Genotropin, Zomacton, Humatrope, Omnitrope.
The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Growth hormone 0.2 mg/kg/week | Active comparator | Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment Receives: Drug: Somatropin |
| Arm 2: Growth hormone 0.3 mg/kg/week | Active comparator | Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment Receives: Drug: Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Growth Velocity (GV) in the first year after treatment
Height (cm) at 0- month visit; height (cm) at 12-month visit
Measured: I year
Secondary outcomes (5)
IGF1- 0,4,8,12 months
IGF-1 will be collected at timepoints - 0,4,8,12 months
Measured: 12 Months
IGFBP3 - 0,4,8,12 months
IGFBP3 will be collected at timepoints - 0,4,8,12 months
Measured: 12 Months
HbA1c - 4,8,12 months
HbA1c will be collected at timepoints 4,8,12 months
Measured: 12 Months
Total T4 or Free T4 - 0,12 months
Total T4 or Free T4 will be collected at timepoints 0,12 months
Measured: 12 Months
TSH - 0, 12 months
TSH will be collected at timepoints 0, 12 months
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start10 Dec 2023
- Primary completion5 Jan 2028 (estimated)
- Study completion5 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Growth DisordersStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin U. Nwosu, MD, Principal investigator, NORTHWELL HEALTH, INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103513
- Sponsor's protocol ID
- 23-0027
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Backelijaw P, Dattani M, Cohen P Rosenfeld R, (2014).Chapter 10: Disorders of Growth Hormone/ Insulin Like Growth Factor Secretion and Action. Shreiner, J (Ed.). Pediatric Endocrinology: Marc Sperling. (chapter 10, page 364, 366). Philadelphia, Saunders
Grumbach MM, Bin-Abbas BS, Kaplan SL. The growth hormone cascade: progress and long-term results of growth hormone treatment in growth hormone deficiency. Horm Res. 1998;49(# Suppl 2):41-57. No abstract available.
PubMed 9716827Blethen SL, MacGillivray MH. A risk-benefit assessment of growth hormone use in children. Drug Saf. 1997 Nov;17(5):303-16. doi: 10.2165/00002018-199717050-00003.
PubMed 9391774Christ ER, Cummings MH, Jackson N, Stolinski M, Lumb PJ, Wierzbicki AS, Sonksen PH, Russell-Jones DL, Umpleby AM. Effects of growth hormone (GH) replacement therapy on low-density lipoprotein apolipoprotein B100 kinetics in adult patients with GH deficiency: a stable isotope study. J Clin Endocrinol Metab. 2004 Apr;89(4):1801-7. doi: 10.1210/jc.2003-031474.
PubMed 15070948Locatelli V, Bianchi VE. Effect of GH/IGF-1 on Bone Metabolism and Osteoporsosis. Int J Endocrinol. 2014;2014:235060. doi: 10.1155/2014/235060. Epub 2014 Jul 23.
PubMed 25147565Boguszewski CL, Meister LH, Zaninelli DC, Radominski RB. One year of GH replacement therapy with a fixed low-dose regimen improves body composition, bone mineral density and lipid profile of GH-deficient adults. Eur J Endocrinol. 2005 Jan;152(1):67-75. doi: 10.1530/eje.1.01817.
PubMed 15762189Hardin DS. Treatment of short stature and growth hormone deficiency in children with somatotropin (rDNA origin). Biologics. 2008 Dec;2(4):655-61. doi: 10.2147/btt.s2252.
PubMed 19707446Straetemans S, Thomas M, Craen M, Rooman R, De Schepper J; BESPEED. Poor growth response during the first year of growth hormone treatment in short prepubertal children with growth hormone deficiency and born small for gestational age: a comparison of different criteria. Int J Pediatr Endocrinol. 2018;2018:9. doi: 10.1186/s13633-018-0064-3. Epub 2018 Oct 22.
PubMed 30377433Reiter EO, Price DA, Wilton P, Albertsson-Wikland K, Ranke MB. Effect of growth hormone (GH) treatment on the near-final height of 1258 patients with idiopathic GH deficiency: analysis of a large international database. J Clin Endocrinol Metab. 2006 Jun;91(6):2047-54. doi: 10.1210/jc.2005-2284. Epub 2006 Mar 14.
PubMed 16537676de Ridder MA, Stijnen T, Hokken-Koelega AC. Prediction of adult height in growth-hormone-treated children with growth hormone deficiency. J Clin Endocrinol Metab. 2007 Mar;92(3):925-31. doi: 10.1210/jc.2006-1259. Epub 2006 Dec 19.
PubMed 17179199Wit JM, Ranke MB, Albertsson-Wikland K, Carrascosa A, Rosenfeld RG, Van Buuren S, Kristrom B, Schoenau E, Audi L, Hokken-Koelega AC, Bang P, Jung H, Blum WF, Silverman LA, Cohen P, Cianfarani S, Deal C, Clayton PE, de Graaff L, Dahlgren J, Kleintjens J, Roelants M. Personalized approach to growth hormone treatment: clinical use of growth prediction models. Horm Res Paediatr. 2013;79(5):257-70. doi: 10.1159/000351025. Epub 2013 May 28.
PubMed 23735882Kristrom B, Dahlgren J, Niklasson A, Nierop AF, Albertsson-Wikland K. The first-year growth response to growth hormone treatment predicts the long-term prepubertal growth response in children. BMC Med Inform Decis Mak. 2009 Jan 12;9:1. doi: 10.1186/1472-6947-9-1.
PubMed 19138407MacGillivray MH, Baptista J, Johanson A. Outcome of a four-year randomized study of daily versus three times weekly somatropin treatment in prepubertal naive growth hormone-deficient children. Genentech Study Group. J Clin Endocrinol Metab. 1996 May;81(5):1806-9. doi: 10.1210/jcem.81.5.8626839.
PubMed 8626839Ranke MB, Schweizer R, Wollmann HA, Schwarze P. Dosing of growth hormone in growth hormone deficiency. Horm Res. 1999;51 Suppl 3:70-4. doi: 10.1159/000053165.
PubMed 10592447Ranke MB, Lindberg A, Chatelain P, Wilton P, Cutfield W, Albertsson-Wikland K, Price DA. Derivation and validation of a mathematical model for predicting the response to exogenous recombinant human growth hormone (GH) in prepubertal children with idiopathic GH deficiency. KIGS International Board. Kabi Pharmacia International Growth Study. J Clin Endocrinol Metab. 1999 Apr;84(4):1174-83. doi: 10.1210/jcem.84.4.5634.
PubMed 10199749
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment
- ClinicalTrials.gov ID
- NCT06103513
- Acronym / sponsor ID
- 23-0027
- Conditions
- Growth Disorders, Growth Failure, Growth Hormone Treatment, Growth
- Keywords
- Growth Hormone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 5 Jan 2028 (estimated)
- Study completion
- 5 Jan 2028 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
Detailed description
Investigators propose a prospective randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years. 25 subjects will be randomized to initiate a dose of 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week (0.18-0.22 mg/kg/week) for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Growth hormone 0.2 mg/kg/week | Active comparator | Drug: SomatropinTwenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment |
| Arm 2: Growth hormone 0.3 mg/kg/week | Active comparator | Drug: SomatropinTwenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 5-15 years
- In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
- Ability to take subcutaneous GH injections nightly
Key exclusion criteria (1 listed)
- Subjects will be excluded if they have GH resistance, or syndromic short stature such as Prader Willi syndrome and Turner syndrome. Patients will also be excluded if they have active malignancies, or systemic illnesses such as heart failure, kidney failure, or liver failure.
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 |
|---|---|---|
| SomatropinAlso: Norditropin, Nutropin AQ, Genotropin, Zomacton, Humatrope, Omnitrope.The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH. | Drug | Arm 1: Growth hormone 0.2 mg/kg/week, Arm 2: Growth hormone 0.3 mg/kg/week |
Primary outcome
Annualized Growth Velocity (GV) in the first year after treatment
Time frame: I year
Height (cm) at 0- month visit; height (cm) at 12-month visit
5 secondary outcomes
IGF1- 0,4,8,12 months
Time frame: 12 Months
IGFBP3 - 0,4,8,12 months
Time frame: 12 Months
HbA1c - 4,8,12 months
Time frame: 12 Months
Total T4 or Free T4 - 0,12 months
Time frame: 12 Months
TSH - 0, 12 months
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- BackgroundBackelijaw P, Dattani M, Cohen P Rosenfeld R, (2014).Chapter 10: Disorders of Growth Hormone/ Insulin Like Growth Factor Secretion and Action. Shreiner, J (Ed.). Pediatric Endocrinology: Marc Sperling. (chapter 10, page 364, 366). Philadelphia, Saunders
- Background: PubMed 9716827Grumbach MM, Bin-Abbas BS, Kaplan SL. The growth hormone cascade: progress and long-term results of growth hormone treatment in growth hormone deficiency. Horm Res. 1998;49(# Suppl 2):41-57. No abstract available.
- Background: PubMed 9391774Blethen SL, MacGillivray MH. A risk-benefit assessment of growth hormone use in children. Drug Saf. 1997 Nov;17(5):303-16. doi: 10.2165/00002018-199717050-00003.
- Background: PubMed 15070948Christ ER, Cummings MH, Jackson N, Stolinski M, Lumb PJ, Wierzbicki AS, Sonksen PH, Russell-Jones DL, Umpleby AM. Effects of growth hormone (GH) replacement therapy on low-density lipoprotein apolipoprotein B100 kinetics in adult patients with GH deficiency: a stable isotope study. J Clin Endocrinol Metab. 2004 Apr;89(4):1801-7. doi: 10.1210/jc.2003-031474.
- Background: PubMed 25147565Locatelli V, Bianchi VE. Effect of GH/IGF-1 on Bone Metabolism and Osteoporsosis. Int J Endocrinol. 2014;2014:235060. doi: 10.1155/2014/235060. Epub 2014 Jul 23.
- Background: PubMed 15762189Boguszewski CL, Meister LH, Zaninelli DC, Radominski RB. One year of GH replacement therapy with a fixed low-dose regimen improves body composition, bone mineral density and lipid profile of GH-deficient adults. Eur J Endocrinol. 2005 Jan;152(1):67-75. doi: 10.1530/eje.1.01817.
- Background: PubMed 19707446Hardin DS. Treatment of short stature and growth hormone deficiency in children with somatotropin (rDNA origin). Biologics. 2008 Dec;2(4):655-61. doi: 10.2147/btt.s2252.
- Background: PubMed 30377433Straetemans S, Thomas M, Craen M, Rooman R, De Schepper J; BESPEED. Poor growth response during the first year of growth hormone treatment in short prepubertal children with growth hormone deficiency and born small for gestational age: a comparison of different criteria. Int J Pediatr Endocrinol. 2018;2018:9. doi: 10.1186/s13633-018-0064-3. Epub 2018 Oct 22.
- Background: PubMed 16537676Reiter EO, Price DA, Wilton P, Albertsson-Wikland K, Ranke MB. Effect of growth hormone (GH) treatment on the near-final height of 1258 patients with idiopathic GH deficiency: analysis of a large international database. J Clin Endocrinol Metab. 2006 Jun;91(6):2047-54. doi: 10.1210/jc.2005-2284. Epub 2006 Mar 14.
- Background: PubMed 17179199de Ridder MA, Stijnen T, Hokken-Koelega AC. Prediction of adult height in growth-hormone-treated children with growth hormone deficiency. J Clin Endocrinol Metab. 2007 Mar;92(3):925-31. doi: 10.1210/jc.2006-1259. Epub 2006 Dec 19.
- Background: PubMed 23735882Wit JM, Ranke MB, Albertsson-Wikland K, Carrascosa A, Rosenfeld RG, Van Buuren S, Kristrom B, Schoenau E, Audi L, Hokken-Koelega AC, Bang P, Jung H, Blum WF, Silverman LA, Cohen P, Cianfarani S, Deal C, Clayton PE, de Graaff L, Dahlgren J, Kleintjens J, Roelants M. Personalized approach to growth hormone treatment: clinical use of growth prediction models. Horm Res Paediatr. 2013;79(5):257-70. doi: 10.1159/000351025. Epub 2013 May 28.
- Background: PubMed 19138407Kristrom B, Dahlgren J, Niklasson A, Nierop AF, Albertsson-Wikland K. The first-year growth response to growth hormone treatment predicts the long-term prepubertal growth response in children. BMC Med Inform Decis Mak. 2009 Jan 12;9:1. doi: 10.1186/1472-6947-9-1.
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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.
Benjamin U. Nwosu, MD principal investigator
NORTHWELL HEALTH, INC.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatropin in people with Growth Disorders and Growth Failure, run by Northwell Health 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 5 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Namma Pollack-Schreiber, MD (516-472-3750, NPollackschr@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized Growth Velocity (GV) in the first year after treatment (time frame: I year). 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 NCT06103513, which also lists 19 linked publications.
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 21 Oct 2026.