Somatropin for Growth Hormone Deficiency and Concussion

(GRIT Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: VA Office of Research and Development

Must not be taking: Growth hormone, Estrogen, Progestin, others

Disqualifiers: Moderate TBI, Schizophrenia, Cancer, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if giving extra growth hormone can help improve the quality of life for adults who have low growth hormone levels and mild brain injuries. Growth hormone treatment has been shown to improve quality of life in adults with growth hormone deficiency.

Will I have to stop taking my current medications?

The trial requires that you have been stable on any psychotropic medications for 4 weeks and on all other hormone treatments for 3 months. You cannot currently use growth hormone, estrogen, progestin, IGF-I, or high doses of glucocorticoids.

What data supports the effectiveness of the drug Somatropin for growth hormone deficiency and concussion?

Research shows that Omnitrope, a form of Somatropin, is effective in treating growth hormone deficiency in both adults and children, improving growth rates and quality of life. Additionally, growth hormone replacement therapy has been shown to improve quality of life in patients with traumatic brain injury, which is related to growth hormone deficiency. ^{1 2 3 4 5}

How is the drug Somatropin unique for treating growth hormone deficiency and concussion?

Somatropin is unique because it is a growth hormone replacement therapy that can improve quality of life in patients with growth hormone deficiency, including those with traumatic brain injury (TBI), a common cause of this deficiency. It is a biosimilar to other growth hormone treatments, meaning it is highly similar to existing options but may offer a more cost-effective alternative. ^{1 2 3 5 6}

Research Team

Jose M. Garcia, MD PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Eligibility Criteria

This trial is for veterans with mild traumatic brain injury (mTBI) and adult growth hormone deficiency (AGHD). Participants must have a diagnosed GH deficiency, experience from combat, stable use of psychotropic medications, and not be using illicit drugs. Pregnant women or those not on contraception are excluded.

Inclusion Criteria

One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey

OEF/OIF/OND Veteran

Score of 1 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)

Exclusion Criteria

I am currently using growth hormone, estrogen supplements, progestin, IGF-I, or high-dose glucocorticoids.

History of moderate or severe TBI

I have a neurological condition, not TBI, affecting my quality of life.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive recombinant human Growth Hormone or placebo daily for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo (Other)
• Somatropin (Growth Hormone Replacement Therapy)

Trial Overview The study aims to see if growth hormone replacement therapy (GHRT) with Somatropin improves quality of life compared to a placebo in patients who have both mTBI and AGHD. It's a controlled test where some get the real treatment and others get an inactive substance.

Participant Groups

Group I: Growth Hormone Replacement Therapy Active Control 1 Intervention

Recombinant Human Growth Hormone

Group II: Placebo Placebo Group 1 Intervention

Placebo

Somatropin is already approved in Canada, Japan, Switzerland for the following indications:

Approved in Canada as Norditropin for:

• Growth hormone deficiency
• Turner syndrome
• Chronic kidney disease
• Short stature homeobox-containing gene (SHOX) deficiency
• Small for gestational age (SGA) with no catch-up growth

Approved in Japan as Nutropin for:

• Growth hormone deficiency
• Turner syndrome
• Chronic kidney disease

Approved in Switzerland as Omnitrope for:

• Growth hormone deficiency
• Turner syndrome
• Chronic kidney disease
• Short stature homeobox-containing gene (SHOX) deficiency
• Small for gestational age (SGA) with no catch-up growth

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Michael E. DeBakey VA Medical Center, Houston, TX Houston, TX

Miami VA Healthcare System, Miami, FL Miami, FL

Atlanta VA Medical and Rehab Center, Decatur, GA Decatur, GA

Minneapolis VA Health Care System, Minneapolis, MN Minneapolis, MN

More Trial Locations

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

In a study involving 186 children with various growth disturbances, Omnitrope® was found to be well tolerated, with 35.6% of patients reporting adverse events, mostly mild, such as headaches and abdominal pain.

The treatment with Omnitrope® led to significant improvements in height standard deviation scores (HSDS) and height velocity standard deviation scores (HVSDS), indicating its effectiveness in promoting growth in children, consistent with previous clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of Omnitrope®, a somatropin biosimilar, in children requiring growth hormone treatment: Italian interim analysis of the PATRO Children study. Iughetti, L., Tornese, G., Street, ME., et al.[2018]

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

Metabolic and quality of life effects of growth hormone replacement in patients with TBI and AGHD: A pilot study. [2023]

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. England pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of Omnitrope®, a somatropin biosimilar, in children requiring growth hormone treatment: Italian interim analysis of the PATRO Children study. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A randomized, double-blind study to assess the efficacy and safety of valtropin, a biosimilar growth hormone, in children with growth hormone deficiency. [2007]

6. Sweden pubmed.ncbi.nlm.nih.gov

Limited Adherence to Growth Hormone Replacement in Patients with Traumatic Brain Injury. [2022]