What is the mechanism of action of this treatment?

Growth Hormone Replacement Therapy (GHRT) for Growth Hormone Deficiency (GHD) involves the use of recombinant human growth hormone (rhGH) to supplement deficient levels. The rhGH binds to growth hormone receptors on tissues, promoting growth, cell reproduction, and regeneration. This treatment is vital for GHD patients as it helps normalize growth in children, improve muscle mass and bone density in adults, and enhance overall quality of life by improving metabolic functions and psychological well-being.

What side effects are associated with this type of intervention?

Growth Hormone Replacement Therapy (GHRT) for treating Growth Hormone Deficiency can have several side effects. Commonly reported side effects include joint and muscle pain, swelling due to fluid retention, and increased insulin resistance, which can lead to diabetes. Other potential side effects are headaches, carpal tunnel syndrome, and increased risk of certain cancers. It is important for patients to discuss these risks with their healthcare provider to weigh the benefits and potential adverse effects of GHRT.

What prior FDA approvals exist?

The FDA has approved several treatments for Growth Hormone Deficiency (GHD), focusing on supplementing deficient growth hormone levels to improve both physiological and psychological functions. Key drugs include recombinant human growth hormone (rhGH) products such as somatropin, which is marketed under various brand names like Genotropin, Humatrope, and Norditropin. These treatments aim to enhance growth in children and improve body composition, bone density, and quality of life in adults with GHD. The efficacy of these treatments has been demonstrated in clinical trials, showing significant improvements in growth parameters and overall well-being.

What other types of research exist?

Promising novel alternatives to Growth Hormone Replacement Therapy for Growth Hormone Deficiency patients include: 1) Vosoritide, a C-type natriuretic peptide analogue, which has shown potential in promoting bone growth and improving physiological functions. 2) Gene therapy approaches targeting the underlying genetic causes of GHD, aiming to restore normal growth hormone production. 3) Soluble FGFR3 therapy, which has demonstrated efficacy in preclinical models by rescuing symptoms and restoring bone growth. These alternatives are still under investigation but represent potential future treatments.

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Growth Hormone Replacement Therapy

Somatropin for Growth Hormone Deficiency and Concussion (GRIT Trial)

Phase 3

Waitlist Available

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Somatropin can cause joint pain, swelling due to fluid retention, muscle pain, numbness or tingling sensations. There may also be increased cholesterol levels and risks associated with changes in blood sugar.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults)

Secondary study objectives

Body Composition

Other study objectives

Pain

Cognition

Depressive and Anxiety Symptoms measured by Depression Anxiety and Stress Scale (DASS-21)

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Growth Hormone Replacement TherapyActive Control1 Intervention

Recombinant Human Growth Hormone

Group II: PlaceboPlacebo Group1 Intervention

Placebo

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Growth Hormone Replacement Therapy (GHRT) for Growth Hormone Deficiency (GHD) involves the use of recombinant human growth hormone (rhGH) to supplement deficient levels. The rhGH binds to growth hormone receptors on tissues, promoting growth, cell reproduction, and regeneration. This treatment is vital for GHD patients as it helps normalize growth in children, improve muscle mass and bone density in adults, and enhance overall quality of life by improving metabolic functions and psychological well-being.