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Testosterone and human growth hormone clinical trial for FSHD

Home / FSHD Research / Testosterone and human growth hormone clinical trial for FSHD

Posted on: Oct 17, 2017

UPDATED October 30, 2017

Researchers at the University of Rochester in New York are conducting a research study to learn more about a potential symptomatic therapy for FSHD. This study may help determine if a combination of drugs (recombinant human growth hormone [rHGH] and testosterone) can be safely given to patients with FSHD and possibly improve walking, strength, muscle mass, quality of life, and functional ability.

The study has recruited 20 men with FSHD between the ages of 18 and 65, who are still able to walk. The volunteers have committed to making five visits (one with an overnight stay) to the University of Rochester. Study procedures include taking the study drugs (testosterone and rHGH), a physical exam, collection of blood samples, muscle strength and function testing, questionnaires, EKGs, and DEXA scans.

According to the NIH Research Portfolio website, the rationale for this study is described as follows: “Large-scale clinical trials have found that testosterone combined with recombinant human growth hormone (rHGH) (combination therapy) is well tolerated and effective in synergistically improving respiratory function, lean body mass, protein synthesis, strength, and aerobic endurance in healthy adult human populations. Both testosterone and rHGH are readily available and approved for human use but have never been formally studied together in a muscular dystrophy population. We propose a 36-week, proof-of-concept clinical study of the safety and tolerability of daily rHGH combined with biweekly testosterone injections in men with FSHD. All participants will be serially and closely monitored during a 24-week period of combination therapy followed by a 12-week washout period. Safety assessments will include monitoring for medication side effects, laboratory abnormalities, physical exam changes, and EKG alterations. As a secondary objective, we will examine the pharmacokinetic effects of combination therapy on lean body mass and serum biomarkers. Participants will also have serial assessments of their ambulation, strength, physical function, patient-reported disease burden, and respiratory function. Ultimately, this study will generate extensive data regarding the clinical safety, pharmacokinetics, and change in body composition and clinical function associated with combination therapy in a predefined FSHD population.”

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Filed Under: FSHD Research

Comments

  1. Ronald D Ferguson DVM says

    November 3, 2017 at 4:27 pm

    I can stand with assistance, but can’t walk. FSH was diagnosed in 1964 in the army. I have seen Dr Richard Zarling, Dr Lawrence Stern. I am a DVM grad from MN in 1964. I would very much like to be admitted to the study. I live in Tucson AZ.

    Reply
    • June Kinoshita says

      November 3, 2017 at 4:40 pm

      The study has met its initial recruitment target, but we’ll post updates if that changes.

      Reply
    • Ronald D Ferguson DVM says

      November 3, 2017 at 4:42 pm

      I was diagnosed with FSH in 1964 in the army. I have seen Dr Richard Zarling and Dr Lawrence Stern.I am DVM grad from MN in 1964. I would very much like to be admitted to the study. I live in Tucson AZ.

      Reply
      • June Kinoshita says

        December 11, 2017 at 2:59 pm

        Hi Ron, the trial has met its recruitment target for now, but if anything changes, we’ll let folks know.

        Reply
  2. Richard Holmes says

    November 3, 2017 at 11:02 pm

    The use of testosterone and HGH may promote lean muscle mass and muscle growth, but aren’t there also concerns of increased risks of cardiac ills, strike, type 2 diabetes and prostate cancer, especially in older men? Will the study weigh possible benefits against possible risks, and make recommendations for whom such treatments might be most beneficial and whom might eye it with caution?

    Reply
  3. Tiberiu says

    November 16, 2017 at 5:22 pm

    i am 25 years old and i am diagnosed with fshd
    I started by myself this study. I saw that i already have a progress. I am in the first month of study. I will keep you informed with the evolution.
    Thanks
    Au revoir from Paris.

    Reply
    • Adam Smith says

      December 10, 2017 at 9:19 pm

      Would love to hear an update on any progress or improvements you are seeing. I am 33 years old and have been diagnosed with FSHD and would love to be involved in one of these studies.

      Reply
      • June Kinoshita says

        December 11, 2017 at 2:58 pm

        We’ll be following the progress of this trial and keep everyone updated!

        Reply
    • Lauren says

      January 10, 2018 at 10:00 am

      Hi there, any update on your study? Would love more info.

      Reply
    • Pierre says

      January 24, 2018 at 8:08 am

      Hey, I am from paris too. Are you french ?
      Bye

      Reply
    • RICKY KLINE says

      November 2, 2018 at 7:58 pm

      How is it going with the treatment?

      Reply
      • Scott Hancock says

        April 18, 2019 at 5:02 pm

        Hello,

        I am very interested in ace-083. I would love to hear how the study went.

        Thanks
        Scott

        Reply
    • Ahsan Ali says

      August 15, 2023 at 12:57 am

      Hi, any update to this study?
      Thanks

      Reply
  4. Anthony says

    December 14, 2017 at 1:31 am

    Any update on this trial ?? I used anabolic steroids ( testosterone 200mg, deca ) when I was 18 years old and was built nice. once I was off of them I noticed my shoulders looked more foward. Turned out I had fshd and since then it was down hill . I’m 38 now and I’m still pretty active as I play ice hockey 3 nights a week on 3 teams. I’m starting to notice more weakness and I would love to see some type of treatment to help with strength and mobility. I was suppose to be in a trial at university of Pennsylvania but it was not with growth hormone or testosterone, it was called ace-083. Please any updates would be appreciated.

    Reply
    • Shyam says

      March 30, 2019 at 6:43 am

      Have u seen any noticeable improvement by ace-083

      Reply
      • June Kinoshita says

        April 1, 2019 at 2:09 pm

        We won’t know until the data are collected, analyzed, and shared by the company. We hope there will an update by the end of this year.

        Reply
  5. Jim Saleh says

    January 10, 2018 at 10:48 am

    Interesting study. Please keep posting results.

    Reply
  6. Gregory Horvay says

    February 6, 2018 at 1:28 am

    Hey June, any more updates on this study?

    Reply
  7. Patricia O'Dell says

    February 28, 2018 at 10:35 pm

    My son was diagnosed at age 18 and is now 30. I would love to hear any updates

    Reply
  8. Paul says

    April 17, 2018 at 1:57 pm

    Hello,
    On the trial website it says it is still recruiting? Is this true?

    Reply
    • June Kinoshita says

      April 23, 2018 at 12:40 pm

      Our understanding is that the trial has met its initial recruitment goal, but volunteers often drop out before they start a trial, so they may appreciate hearing from others who are willing to participate, in case they need additional volunteers.

      Reply
  9. sheryl vandine says

    September 15, 2018 at 4:37 pm

    Hello. Did the Testosterone and human growth hormone clinical trial for FSHD start as expected? Are there any preliminary results yet?

    Reply
    • June Kinoshita says

      September 17, 2018 at 9:10 pm

      The trial has started but results will not be available for several years.

      Reply
  10. Just a dude with FSHD says

    April 10, 2019 at 4:04 pm

    This study should be done with people taking testosterone and HGH who also strength train. Anabolic steroids by themselves increase muscle and strength in healthy individuals but do so much more in those that strength train already. I think this lack of exercise within this trial is going to affect the results. There’s already been a few studies of anabolics with other muscular dystrophies showing they increase lean body mass but not strength but in all of these there’s no exercise regime. At this point it’s like they’re trying the same strategies but expecting different results, and it’s irritating.

    Reply
    • June Kinoshita says

      April 11, 2019 at 11:10 am

      You make a valid point. Clinical trials should consider controlling for physical activity. We’d like to see a study design that compares an aerobic exercise regimen with and without a drug (whether it be testosterone and HGH, or ACE-083). Although there are challenges to standardizing the amount of daily exercise that the study participants are doing, that would be better than leaving it to chance.

      Reply
      • Chelsea says

        May 11, 2019 at 11:40 am

        June my son was diagnosed with Myotonic Dystrophy. I’m not sure of the differences between three dystrophies but feel this study could help my child also. Please respond and let me know if this is true. He is just wasting away to nothing. He is only 20.

        Reply
  11. Mike says

    May 17, 2019 at 9:08 am

    Very interested in any results so I can share them with my physician. It’s been servers years since this was started. Should have some preliminary results?

    Reply
    • June Kinoshita says

      May 17, 2019 at 4:28 pm

      The study is still going on and results are not expected for a couple more years. The study only has the capacity to dose one patient per month, which is why it takes so long.

      Reply
  12. Derrick Dunn says

    January 17, 2020 at 7:13 am

    Testosterone is basically a sex hormone. It plays a pivotal role in the body. It regulates sex drive, bone mass, strength, and fat distribution. It is a male hormone which can develop and maintain the male attributes. The competitive spirit of an individual is influenced by the amount of testosterone that his body contains. If your testosterone level is high, then you might stay safe from the diseases like hair loss. It increases the muscle mass and allows you to do workout more productively. To improve your verbal memory and thinking ability, you have to maintain a good testosterone efficiency.

    Reply
  13. Tom says

    May 5, 2020 at 2:53 am

    I wonder if there are more newer studies like this being carried out? It would be interesting to know to compared these results.

    Reply
  14. Mark says

    September 28, 2021 at 4:52 am

    I wonder whether there is any update on the status of the study (was it affected by COVID-19)?

    Reply
  15. Jenny Ellis says

    March 29, 2023 at 6:53 am

    Hi There,
    I’m curious to know if anything came of this trial?

    Reply

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