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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

GRIT Trial Summary

This trial will test if growth hormone replacement therapy can help improve quality of life for people with adult growth hormone deficiency and mild traumatic brain injury.

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.Check my eligibility

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.See study design

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.

GRIT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Body Composition

Other outcome measures

Pain

Cognition

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

+2 more

GRIT 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,431 Total Patients Enrolled

Jose M. Garcia, MD PhDStudy ChairVA Puget Sound Health Care System Seattle Division, Seattle, WA

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Somatropin (Growth Hormone Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04867317 — Phase 3

Growth Hormone Deficiency Research Study Groups: Growth Hormone Replacement Therapy, Placebo

Growth Hormone Deficiency Clinical Trial 2023: Somatropin Highlights & Side Effects. Trial Name: NCT04867317 — Phase 3

Somatropin (Growth Hormone Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04867317 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA condone the use of Growth Hormone Replacement Therapy?

"Growth Hormone Replacement Therapy is considered to be safe, as it has received a score of 3."

Answered by AI

Are we currently looking for participants in this experiment?

"Unfortunately, this study is no longer enrolling new patients. The listing on clinicaltrials.gov shows that the study was initially posted on 2023-03-01 and was last updated on 2022-06-23. Although this study has completed recruitment, there are still 1029 other trials searching for patients."

Answered by AI

Have these treatments been used before in patients?

"Growth Hormone Replacement Therapy (GHRT) has been the focus of medical research since 2005. The first trial, sponsored by BioPartners GmbH, took place that year and involved 144 participants. After the successful first Phase 3 trial, GHRT received drug approval and today there are 35 live studies being conducted in 170 cities across 45 countries."

Answered by AI

Are there precedent clinical trials for Growth Hormone Replacement Therapy?

"There are currently 35 active clinical studies related to Growth Hormone Replacement Therapy. Of these, 14 are in Phase 3. Many of these research sites for Growth Hormone Replacement Therapy are located in Philadelphia, but there are a total of 645 sites across the country running these clinical trials."

Answered by AI

For what medical reasons do doctors prescribe Growth Hormone Replacement Therapy?

"Growth Hormone Replacement Therapy can not only improve general surgery outcomes, but also be used to treat short stature, open epiphyses, and antiretroviral therapy."

Answered by AI

Does this study have an age limit?

"In order to participate in this trial, patients must fall between the ages of 21 and 55. Out of the 998 total trials, 220 are for patients younger than this study's age requirement and 758 are for patients older than the age limit."

Answered by AI

How can I sign-up for this opportunity?

"This trial is looking for 172 participants with hypophysial dwarfism who are aged between 21 and 55. The most notable criteria that candidates must meet are as follows: a score of 1 or more on the Combat Experiences sub-scale of the Deployment Risk and Resilience Inventory-2 (DRRI-2), 3-month stability on all other hormone treatments, being an OEF/OIF/OND Veteran, having one or more TBIs on the Military-specific sub-domains of the Boston Assessment of Traumatic brain injury-Lifetime (BAT-L), GH deficiency diagnosed by:"

Answered by AI

How many volunteers are required for this experiment?

"Unfortunately, this trial is no longer looking for new patients. The study was originally posted on 2023-03-01 and was updated for the last time on 2022-06-23. However, there are still 994 other clinical trials actively recruiting patients with hypophysial dwarf and 35 studies for Growth Hormone Replacement Therapy that are currently enrolling participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

2024. "Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04867317.

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