Growth Hormone Therapy for Human Growth Hormone Deficiency

Overseen By Vijay M Baragi, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Center for Neurological Studies

Disqualifiers: Brain disease, Diabetes, Malignant disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have hormone deficiencies like low cortisol, testosterone, or thyroid levels, these must be corrected before participating.

What data supports the effectiveness of the drug for treating growth hormone deficiency?

Research shows that Omnitrope, a type of growth hormone similar to Genotropin, is effective and safe for adults with growth hormone deficiency, as seen in studies like the PATRO Adults study and the NordiNet International Outcome Study. ^{1 2 3 4 5}

Is growth hormone therapy generally safe for humans?

Research on Omnitrope, a type of growth hormone therapy, shows that most side effects are mild or moderate. In studies with both children and adults, some patients experienced adverse events, but serious issues like diabetes were not reported, and any tumors were benign and unrelated to the treatment. ^{1 3 5 6 7}

How is the drug Omnitrope unique for treating growth hormone deficiency?

Omnitrope is a biosimilar to Genotropin, meaning it is designed to be very similar to an existing growth hormone drug but may offer a more cost-effective option. It has been shown to be safe and effective for long-term use in both children and adults with growth hormone deficiency. ^{1 2 3 8 9}

Research Team

Randall R Benson, MD

Principal Investigator

Vice President and Medical Director

Eligibility Criteria

This trial is for retired NFL players under 76 years old with growth hormone deficiency (GHD) diagnosed by a neurologist and endocrinologist. They must understand the study, be willing to participate, and have been retired for at least one year. Those with diabetes, pre-existing brain diseases other than concussion or TBI, conditions affecting assessments, contraindications to GH therapy, active cancer, acute illnesses or untreated hormonal deficiencies cannot join.

Inclusion Criteria

You must have stopped playing football for at least one year.

I am younger than 76 years old.

The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study.

Exclusion Criteria

I currently have cancer.

I cannot take growth hormone therapy due to health risks.

I do not have any acute critical illnesses, heart failure, or acute respiratory issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive growth hormone replacement therapy or placebo to evaluate the efficacy on cognitive functions

52 weeks

Regular visits throughout the year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Growth Hormone
• Placebo

Trial Overview The trial tests if growth hormone (GH) improves cognitive functions in these athletes compared to a placebo. Participants are randomly assigned to receive either GH or placebo without knowing which they're getting. After this phase ends, there's an open-label extension where everyone knows they're receiving GH.

Participant Groups

Group I: Growth Hormone Experimental Treatment 1 Intervention

Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).

Group II: Saline Placebo Group 1 Intervention

Saline-placebo via auto-injector pens (Haselmeier Inc).

Growth Hormone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Somatropin for:

• Growth hormone deficiency
• Turner syndrome
• Prader-Willi syndrome
• Chronic kidney disease
• Short stature due to Noonan syndrome
• Short stature due to Turner syndrome
• HIV-associated wasting

Approved in European Union as Somatropin for:

• Growth hormone deficiency
• Turner syndrome
• Prader-Willi syndrome
• Chronic kidney disease
• Short stature due to Noonan syndrome
• Short stature due to Turner syndrome

Approved in Canada as Somatropin for:

• Growth hormone deficiency
• Turner syndrome
• Prader-Willi syndrome
• Chronic kidney disease
• Short stature due to Noonan syndrome
• Short stature due to Turner syndrome

Who Is Running the Clinical Trial?

Center for Neurological Studies

Lead Sponsor

Trials

1

Recruited

40+

Novo Nordisk A/S

Industry Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Findings from Research

In a study of 67 Italian patients with growth hormone deficiency, Omnitrope® was found to be effective in improving health markers like insulin-like growth factor-1 levels and body composition over an average treatment duration of 45.4 months.

While 55.2% of patients experienced adverse events, none were deemed related to Omnitrope®, indicating that it is generally safe for long-term use in adults with growth hormone deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of Omnitrope® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study. Ferone, D., Profka, E., Gasco, V., et al.[2018]

In a study involving 3180 adult patients with growth hormone deficiency followed for up to 12.2 years, growth hormone replacement therapy showed significant improvements in body composition, including reductions in waist circumference and body mass index (BMI).

The long-term use of growth hormone replacement was found to be safe, with no new safety concerns identified, supporting its effectiveness and safety in clinical practice over more than 10 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth hormone replacement in adults: Real-world data from two large studies in US and Europe. Weber, MM., Gordon, MB., Höybye, C., et al.[2021]

The PATRO Adults study is a large, long-term observational study designed to assess the safety and efficacy of somatropin (Omnitrope(®)) in adults with growth hormone deficiency, involving multiple centers across Europe.

This study will provide valuable insights into the long-term effects of Omnitrope(®) on various health factors, including diabetes development, tumor recurrence, and overall quality of life, while monitoring adverse events and safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency. Beck-Peccoz, P., Minuto, F., Leal-Cerro, A., et al.[2021]

In a study involving 1447 adults with growth hormone deficiency (GHD), biosimilar recombinant human growth hormone (Omnitrope®) demonstrated a favorable safety profile, with 73% of patients reporting mild-to-moderate adverse events, and only 1.9% experiencing serious treatment-related adverse events.

The treatment was effective, as indicated by a significant increase in IGF-I levels from a baseline of -2.34 to -0.23 after 12 months, showing that Omnitrope® can effectively manage GHD in real-world clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of replacement with biosimilar growth hormone in adults with growth hormone deficiency: results from an international, post-marketing surveillance study (PATRO Adults). Höybye, C., Beck-Peccoz, P., Murray, RD., et al.[2021]

In a study of 291 children treated with the somatropin biosimilar Omnitrope® for an average of 33 months, the treatment showed acceptable safety with only 12% experiencing adverse events, primarily mild issues like headaches and abdominal pain.

The effectiveness of Omnitrope® was demonstrated by significant improvements in height standard deviation scores (HSDS) and height velocity standard deviation scores (HVSDS), indicating positive growth outcomes over a treatment period of up to 6.5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort. Iughetti, L., Antoniazzi, F., Giavoli, C., et al.[2021]

A study involving 294 patients in the USA and 6206 patients in 13 other countries found that treatment with Omnitrope® (rhGH) is well tolerated, with most adverse events being mild or moderate and no cases of diabetes or hyperglycemia reported.

After 3 years of treatment, both US and international rhGH-naïve patients showed significant improvements in height, with mean height SD scores increasing by +1.25 in the US and +1.35 internationally, indicating the efficacy of Omnitrope® in promoting growth in children with growth hormone deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of Omnitrope® (somatropin) in PATRO Children: a multi-center, post-marketing surveillance study comparison of US and international cohort data. Backeljauw, P., Kanumakala, S., Loche, S., et al.[2022]

The PATRO Children study, involving 1837 patients across 184 sites in 10 European countries, is monitoring the long-term safety and efficacy of somatropin (Omnitrope(®)) in children requiring growth hormone treatment, with initial results showing no confirmed cases of diabetes or malignancies.

Efficacy data from the study are consistent with previous findings, indicating that Omnitrope(®) is safe for use in children, including those with specific conditions like Prader-Willi syndrome, and will provide further insights into its long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) in children requiring growth hormone treatment. Pfäffle, R., Schwab, KO., Marginean, O., et al.[2021]

In a study of 197 children with growth hormone deficiency treated with recombinant human growth hormone (r-hGH) for one year, significant increases in height velocity were observed across different treatment groups, indicating the efficacy of r-hGH in promoting growth.

The treatment was found to be safe, with minimal side effects; only a few patients experienced local discomfort at the injection site, and only 3 developed low-titer antibodies to hGH that did not affect growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Authentic recombinant human growth hormone. Results of a multicenter clinical trial in patients with growth hormone deficiency. Rasmussen, LH., Zachmann, M., Nilsson, P.[2007]

In a phase III study involving 70 prepubertal children with growth hormone deficiency, long-term treatment with Omnitrope (0.03 mg/kg/day) resulted in significant growth improvements over 4 years, including an average height increase of 31.1 cm.

Omnitrope was found to be safe and well tolerated, with significant increases in serum levels of IGF-1 and IGFBP-3, indicating effective stimulation of growth-related hormones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of the recombinant human growth hormone Omnitrope® in the treatment of Spanish growth hormone deficient children: results of a phase III study. López-Siguero, J., Borrás Pérez, MV., Balser, S., et al.[2013]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of Omnitrope® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study. [2018]

2. Scotland pubmed.ncbi.nlm.nih.gov

Growth hormone replacement in adults: Real-world data from two large studies in US and Europe. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of replacement with biosimilar growth hormone in adults with growth hormone deficiency: results from an international, post-marketing surveillance study (PATRO Adults). [2021]

5. Italy pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of Omnitrope® (somatropin) in PATRO Children: a multi-center, post-marketing surveillance study comparison of US and international cohort data. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) in children requiring growth hormone treatment. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Authentic recombinant human growth hormone. Results of a multicenter clinical trial in patients with growth hormone deficiency. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of the recombinant human growth hormone Omnitrope® in the treatment of Spanish growth hormone deficient children: results of a phase III study. [2013]