Growth Hormone Deficiency Symptoms & Causes | Boston Children …

We understand that you may have a lot of questions when your child is diagnosed with growth hormone deficiency. Is it dangerous? Will it affect my child long term? What do we do next? Weve tried to provide some answers to those questions here, and our experts can explain your childs condition fully.

What is growth hormone deficiency?

Growth hormone deficiency is a complex problem that can take different forms from patient to patient.

Growth hormone is a protein produced by the pituitary gland, which is located near the base of the brain and attached to the hypothalamus (a part of the brain that helps to regulate the pituitary gland). If the pituitary gland or the hypothalamus is malformed or damaged, it may mean that the pituitary gland cant produce growth hormone.

If the pituitary gland is lacking in multiple pituitary hormones, the condition is called hypopituitarism.

How do you define "normal" growth?

Growth rates vary considerably from child to child. But measured in height, average "normal" growth is often described as:

If your child is less than the 3rd percentile in height for a child of his age, that can be a red flag for growth hormone deficiency.

Some research suggests that there are additional complications from growth hormone deficiency, including:

Damage to the pituitary gland or hypothalamus may be the result of an abnormal formation that occurred before your child was born (congenital) or something that occurred during or after birth (acquired).

Congenital growth hormone deficiency can occur if there are mutations in genes for factors that are important in pituitary gland development, or in receptors and factors (including growth hormone) along the growth hormone pathway; to date, however, the cause of most of these cases is unknown.

Acquired causes of growth hormone deficiency include:

It's also important to remember that growth hormone deficiency is only one of many conditions that may affect your childs growth. Your childs short stature may be caused by other syndromes, and growth failure may be due to decreased nutritional intake, gastrointestinal disorders, diseases that have increased metabolic demand or hypothyroidism.

Since growth takes place over many years, and since children grow at different rates, symptoms of growth hormone deficiency may be hard to identify. In addition to noticeably slow growth with normal body proportions, signs may include:

Growth hormone deficiency has no affect on a childs intelligence.

These symptoms may resemble other conditions, so be sure to always consult your child's physician for a diagnosis.

Q: What is growth hormone deficiency?

A: Growth hormone is a protein produced by the pituitary gland, which is located near the base of the brain and attached to the hypothalamus (a part of the brain that helps to regulate the pituitary gland). If the pituitary gland or the hypothalamus is malformed or damaged, it may mean that the pituitary gland cant produce growth hormone.

If the pituitary gland is lacking in multiple pituitary hormones, the condition is called hypopituitarism.

Q: What causes growth hormone deficiency?

A: Damage to the pituitary gland or hypothalamus may be the result of an abnormal formation that occurred before your child was born (congenital) or something that occurred during or after birth (acquired).

Your childs short stature may also be caused by other syndromes, and growth failure may be due to decreased nutritional intake, medications, gastrointestinal disorders, diseases that have increased metabolic demand or hypothyroidism.

Q: Is growth hormone deficiency treatable?

A: Treatment of growth hormone deficiency involves regular injections of synthetic human growth hormone. Children receive daily injections. Treatment usually lasts several years, although results are often seen as soon as three to four months after the injections are started.

The earlier the treatment for growth hormone deficiency is started, the better chance the child will have of attaining her normal or near-normal adult height. However, not all children respond well to growth hormone treatment.

Q: How safe is treatment for growth hormone deficiency?

A: While there are many potential side effects, particularly if growth hormone is used to treat children who don't have a true hormone deficiency, researchers generally agree that treatment with human growth hormone is safe and effective.

Q: Will growth hormone deficiency affect my childs intelligence?

A: Growth hormone deficiency has no effect on a childs intelligence.

You and your family are key players in your childs medical care. Its important that you share your observations and ideas with your childs health care provider and that you understand your providers recommendations.

If your child is experiencing symptoms of growth hormone deficiency and youve set up an appointment, you probably already have some ideas and questions on your mind. But at the appointment, it can be easy to forget the questions you wanted to ask. Its often helpful to jot them down ahead of time so that you can leave the appointment feeling like you have the information you need.

If your child is old enough, you may want to suggest that she write down what she wants to ask her health care provider, too.

Some of the questions you may want to ask include:

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Growth Hormone Deficiency Symptoms & Causes | Boston Children ...

List of Growth hormones (human growth hormone) – Drugs.com

Other names: human growth hormone, somatotropin

Growth hormones are hormones that stimulate growth and cell reproduction and regeneration. They are released naturally by the anterior pituitary gland, a pea-sized gland located at the base of the skull. Growth hormone deficiency (GHD) is more likely to affect children rather than adults and is a symptom of several genetic diseases such as Prader-Willi syndrome and Turner Syndrome. GHD is also more likely in children with cleft lips or palates. Infection, head injuries, and radiation treatment may lead to acquired GHD. Naturally occurring growth hormone is also known as somatotropin.

A synthetic version of growth hormone, somatropin, is used to treat disorders of growth hormone production or deficiency. Symptoms in children include failure to meet height and weight growth standards.

Filter byAll conditionsAdult Human Growth Hormone DeficiencyAIDS Related WastingCachexiaGrowth Hormone Reserve TestGrowth Retardation, Chronic Renal FailureIdiopathic Short StatureLipodystrophyNoonan's SyndromePediatric Growth Hormone DeficiencyPrader-Willi SyndromeShort Bowel SyndromeShort Stature for AgeTurner Syndrome

Medical conditions associated with growth hormones:

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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List of Growth hormones (human growth hormone) - Drugs.com

What You Need to Know About Human Growth Hormone Levels

Human growth hormone (HGH) levels vary by age and sex.

HGH is released into the bloodstream by the pituitary gland. The primary function of HGH is tissue growth in children. In adults, HGH is responsible for cellular repair and regeneration. HGH also plays a role in many bodily functions and processes, primarily fat metabolism. Therefore, it plays a role in maintaining muscle tone, health, and fitness.

Your HGH levels vary by age. As you might imagine, HGH levels are highest in children.

The normal range for HGH level is typically:

As men age, there is a natural decline in HGH levels. HGH levels can and do fluctuate throughout the day. This is why doctors prefer to talk about normal HGH levels as a range, rather than a fixed ng/mL level.

Furthermore, because HGH levels in the blood vary at any given time, doctors prefer to establish the normal ranges of HGH by age based on IGF-1 levels. IGF-1 is another hormone. It is created by the liver and stimulates HGH production. IGF-1 levels are more constant than HGH levels and give a clear picture of ability to produce and release HGH.

The following chart (provided by LabCorp our testing facility) gives the normal IGF-1 for men by age.

AGE In Years

Male (ng/mL)

31 to 35

88246

36 to 40

83233

41 to 45

75216

46 to 50

67205

51 to 55

61200

56 to 60

54194

61 to 65

49188

66 to 70

47192

71 to 75

41179

76 to 80

37172

81 to 85

34165

86 to 90

32166

>90

Not established

Normal levels of human growth hormone (HGH) levels vary by age and sex.

Low HGH levels may indicate problems with your pituitary gland. Below normal HGH levels by age in men can result in a reduced sense of wellbeing, increased fat, increased risk of heart disease, and weakening muscles and bones.

While it is rarer than low HGH levels, some people do suffer from HGH levels that are too high. If your HGH levels are higher than normal, it can result in a rare condition known as acromegaly, in which patients have swelling of the hands and feet and altered facial features. Extremely high levels of HGH in children can cause gigantism, or growth to unusually tall stature. In almost all cases of acromegaly or gigantism, the above normal HGH levels are the result of a pituitary tumor.

HGH levels in women also vary by age just as they do in men. Again, we use IGF-1 levels to establish normal HGH levels in women by age. The following chart shows the normal IGF-1 levels in women by age.

AGE In Years

Female (ng/mL)

31 to 35

73243

36 to 40

69227

41 to 45

62204

46 to 50

57195

51 to 55

53190

56 to 60

46172

61 to 65

42169

66 to 70

38163

71 to 75

37165

76 to 80

35165

81 to 85

34172

86 to 90

34178

>90

Not established

HGH levels fluctuate throughout the day, so normal levels of HGH are expressed in a range, rather than a fixed level.

In women, HGH levels drop to their lowest after menopause. However, sometimes women who are still in their childbearing years, might require growth hormone therapy. What impact does growth hormone have on pregnancy? There have been some studies that indicate for women who are having trouble getting pregnant, growth hormone therapy may increase fertility. Once a woman becomes pregnant, her body automatically produces excessive HGH and IGF-1 for the developing fetus. Supplemental HGH is not recommended for pregnant women.

HGH levels decrease if you have a disease, injury, or genetic condition that impacts your pituitary glands ability to make HGH. HGH levels also decline naturally as men and women age. This natural drop in HGH as you grow older can result in age-related GHD.

Since your growth hormone levels can and do change throughout the day, instead of a test that measures the HGH level in your blood at any given time, we test for the level of IGF-1.

During the test a blood sample will be drawn from a vein in your arm. Since HGH levels fluctuate throughout the day, we do not test for HGH, but rather IGF-1. IGF-1 mirrors HGH excesses and deficiencies, but the level in the blood is stable throughout the day, making it a more useful indicator of average HGH levels than testing for HGH.

Before performing specific HGH testing, if the IGF-1 level is found to be normal for age and sex, growth hormone deficiency (GHD) can be ruled out, and more definitive testing is not necessary.

There could be some ways to naturally increase your HGH levels. Exercise, particularly strength training, or high intensity interval training can raise HGH levels. Here are some other ways that both men and women can naturally raise their HGH levels.

The above lifestyle changes could help keep your HGH level close to normal for your age and gender. However, if the results of your HGH or IGF-1 test indicate you have a growth hormone deficiency, or GHD, the only way that it can be treated is with hormone replacement therapy.

If your growth hormone level is determined to be below normal, depending on your age, gender and symptoms you will likely be prescribed growth hormone injections. Growth hormone injections are used to treat GHD in children and adults.

Growth hormone injections are only available with a doctors prescription. There are many anti-aging benefits of HGH replacement therapy. One of the main benefits of growth hormone replacement, is that it will improve your ability to burn fat and build lean muscle. This benefit alone will go a long way to making you look and feel younger.

However, the many benefits of HGH do not stop there. HGH therapy:

HGH therapy is a safe and effective way to treat lower than normal HGH levels.

Now that you know a bit more about normal and low HGH levels, why not contact us today, and find out more about the many life-changing benefits of HGH and other hormone replacement therapies.

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What You Need to Know About Human Growth Hormone Levels

Growth Hormone Therapy | Norditropin (somatropin) Injection

Selected Important Safety Information

Do not use Norditropin if: you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems; you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea; you have cancer or other tumors; you are allergic to somatropin or any of the ingredients in Norditropin; your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy); you are a child with closed bone growth plates (epiphyses).

Indications and Usage

What is Norditropin (somatropin) injection?

Norditropin is a prescription medicine that contains human growth hormone and is used to treat:

Important Safety Information (contd)

Before taking Norditropin, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Norditropin may affect how other medicines work, and other medicines may affect how Norditropin works.

How should I use Norditropin?

What are the possible side effects of Norditropin? Norditropin may cause serious side effects, including:

The most common side effects of Norditropin include:

Pleaseclick herefor NorditropinPrescribing Information.

Norditropin is a prescription medication.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800- FDA-1088.

Talk to your health care provider and find out if Norditropin is right for you or your child.

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Growth Hormone Therapy | Norditropin (somatropin) Injection

Igor Vovkovinskiy, Who At 7-Foot-8 Was The Tallest Man In The U.S., Has Died – NPR

Igor Vovkovinskiy, the country's tallest person at 7-foot-8, died in Minnesota at the age of 38. His family says he died of heart disease. Haraz N. Ghanbari/AP hide caption

Igor Vovkovinskiy, the country's tallest person at 7-foot-8, died in Minnesota at the age of 38. His family says he died of heart disease.

ROCHESTER, Minn. Igor Vovkovinskiy, the tallest man in the United States, has died. He was 38.

His family said the Ukrainian-born Vovkovinskiy died of heart disease on Friday at the Mayo Clinic in Rochester. His mother, Svetlana Vovkovinska, an ICU nurse at Mayo, initially posted about his death on Facebook.

Vovkovinskiy came to the Mayo Clinic in 1989 as a child seeking treatment. A tumor pressing against his pituitary gland caused it to secrete abnormal levels of growth hormone. He grew to become the tallest man in the U.S. at 7 feet, 8.33 inches (2 meters, 34.5 centimeters) and ended up staying in Rochester.

His older brother, Oleh Ladan of Brooklyn Park, told the Star Tribune of Minneapolis that Vovkovinskiy was a celebrity when he arrived from Ukraine because of his size and the flickering Cold War of the late 1980s. But Ladan said Vovkovinskiy "would have rather lived a normal life than be known."

Vovkovinskiy met President Barack Obama during a health care reform rally in 2009, when the president noticed him near the stage wearing a T-shirt that read, "World's Biggest Obama Supporter." Ben Garvin/AP hide caption

Vovkovinskiy appeared on "The Dr. Oz Show" and was called out by President Barack Obama during a campaign rally in 2009, when the president noticed him near the stage wearing a T-shirt that read, "World's Biggest Obama Supporter." In 2013, he carried the Ukrainian contestant onto the stage to perform in the Eurovision Song Contest.

When he was 27, Vovkovinskiy traveled to New York City and was declared America's tallest living person by a Guinness World Records adjudicator on Oz's show. He edged out a sheriff's deputy in Virginia by one-third of an inch.

He issued a plea in 2012 to cover the estimated $16,000 cost for specially made shoes that wouldn't cause him crippling pain. At the time, he said he hadn't owned a pair for years that fit his size 26, 10E feet. Thousands donated more than double what he needed. Reebok provided the custom shoes for free.

Vovkovinskiy was born Sept. 8, 1982, in Bar, Ukraine, to Vovkovinska and Oleksandr Ladan, according to Ranfranz and Vine Funeral Home, which is holding a memorial service on Saturday. His father died earlier.

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Igor Vovkovinskiy, Who At 7-Foot-8 Was The Tallest Man In The U.S., Has Died - NPR

Can what you eat save you from COVID-19? – The Jerusalem Post

Could good nutrition save people from developing severe COVID-19?

According to experts in the field, nutrition is the biggest coronavirus risk factor that not enough people are talking about.

We have two epidemics: obesity and COVID-19, said Dr. Mariela Glandt, a Harvard University and Columbia University trained endocrinologist and nutritionist who now lives in Israel and runs a clinic for diabetics in Ramat Aviv.

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She said, As long as the pandemic is still going on, anyone who cares about their health should do everything they can to improve the risk factors that they control among them diet.

A poor diet, like the modern American diet, with its junk food, ultra-processed starches and cheap fats, causes metabolic dysfunction that can be a disaster when its combined with the coronavirus, Glandt wrote in an eBook titled How to Eat in the Time of COVID-19 that she recently published with Ross Wollen and Jessica Apple.

The book was published by ASweetLife, which describes itself as the Internets trusted authority on the art of living well with diabetes.

Severe COVID-19 hospitalization, treatment in an intensive care unit, mechanical ventilation and even death has been associated with higher body mass index, the Centers for Disease Control has said.

Specifically, obesity defined by BMI increases the odds of hospitalization by 76%, Boaz showed in a paper that is soon to be published but has not yet been peer reviewed. She said the likelihood of ICU admission increases by 67%, mechanical ventilation by 119% and death by 37% all according to recent studies.

Moreover, a study that was published in the peer-reviewed journal PLOS One at the end of last month showed that people with high sugar values but who were not diagnosed with diabetes were also at risk of severe COVID-19 morbidity or mortality.

The researchers from Hebrew University of Jerusalem, Meuhedet Health Services, Jerusalem College of Technology and Hadassah-University Medical Center conducted a retroactive study among all individuals over the age of 18 who were insured by Meuhedet and contracted the virus between March and October 2020.

Of the 37,121 people who tested positive, 707 of them had severe disease, including 244 who died.

THE NORMAL blood sugar level in an adult is 70 to 100 milligrams per deciliter (mg/dL) of blood sugar after an eight-hour fast. Patients with 105-125 mg/dL were 1.5 times more likely to have severe COVID than patients with sugar lower than 105. Patients with between 125-140 mg/dL were twice as likely to develop complications.

The aim of the study was to identify risk factors for severe coronavirus illness that can be treated ahead of time, explained Dr. Michal Shauly-Aharonov of the Jerusalem College of Technology.

Obesity, high blood pressure, diabetes and many forms of cardiovascular disease are symptoms of an underlying medical condition called insulin resistance, Glandt wrote in her book.

Insulin is the hormone that allows your body to utilize the glucose in the food that you eat. Normally, this is a healthy and natural process insulin levels rise when eating, and subside to very low levels between meals, Glandt explained. Insulin is a storage and growth hormone and it is critical that there be a balance between high and low levels.

But when you eat a diet full of sweets and starches, your insulin production can grow out of control. Eventually, your cells become resistant to insulin, dulling its effect, which just causes your body to produce even more of it, as your body struggles to move glucose [sugar] out of your blood and into your cells, she said.

High sugar levels mean there is no more room to store sugar in a persons cells and so the sugar stays in the blood. If a person stops bringing sugar into their body, their sugar level will decline.

Through her own clinic, she has managed to get 97% of clients off insulin through diet management. The average client loses eight kg. (18 lbs.) in the first six months. Moreover, some 65% of clients normalize their blood sugar to the extent that they are no longer considered diabetic.

She advocates for the ketogenic diet, which includes avoiding all seed oils, such as canola, soybean, sunflower and corn; avoiding all sugars; and keeping complex carbohydrates to a minimum.

Boaz, on the other hand, has said that a modified Mediterranean diet to achieve the right balance, which includes fish, nuts, hummus, tahini and refried beans, is high in fruits and vegetables, whole grains and olive oils and low in processed foods.

This particular pandemic highlighted the impact that obesity can have on the immune system, Boaz said.

She stressed that public health policy should be directed at improving diet quality, especially among youths who are much more likely to follow healthful practices if taught from an early age.

Logic would tell you, Boaz said, being adequately nourished and maintaining a healthy diet is always to your benefit.

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Can what you eat save you from COVID-19? - The Jerusalem Post

NZME Limited (NZX: NZM) Half Year Results to 30 June 2021 – sharechat.co.nz – sharechat

NZME Limited has today announced its financial results for the half year ended 30 June 2021, reporting Statutory Net Profit After Tax (NPAT) of $5.6 million, up 85% on the corresponding period in 2020.

NZME also announced growth in Operating Earnings before Interest, Tax, Depreciation and Amortisation (EBITDA) to $30.1 million for the half year, representing 4% growth in Operating EBITDA against the first half of 2020. Operating revenue was $172.5m which was 9% higher than the first half of 2020.

NZME is delighted to share a set of results that feature earnings growth and a further reduction in net debt, said NZME CEO Michael Boggs.

Emerging from the significant disruption encountered in 2020 NZME has maintained a steadfast focus on key strategic priorities. This has meant that as New Zealands many commercial sectors are steadily rebuilding their investment in audience engagement, NZMEs advertising revenues continue to approach the levels achieved in 2019, before the pandemic struck, said Boggs.

NZMEs Net Debt was reduced by a further $15.2 million during the half year to $18.6 million and is now below NZMEs target leverage ratio.

A rigorous commercial discipline and a continual focus on managing the cost base as business activity recovers has improved NZMEs ongoing Capital Management performance and has supported the continued strengthening of NZMEs Balance Sheet, said NZME Chairman Barbara Chapman.

NZME today announced that given the significant reduction in debt and based on the business outlook and NZMEs capital requirements the NZME board has declared a fully imputed and fully franked dividend of 3.0 cps.

Please see the links below for details

NZME 2021 Half Year Results - Cover Note

NZME 2021 Half Year Results NZX Form

NZME 2021 Half Year Results Announcement

NZME 2021 Half Year Results Presentation

NZME 2021 Consolidated Interim Financial Statements

Distribution Notice - NZX Form

Source: NZME Limited

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Ascendis Pharma A/S Announces Second Quarter 2021 Financial Results and Business Update Conference Call on August 25 – Stockhouse

COPENHAGEN, Denmark, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, today announced that the company will hold a conference call and live webcast on Wednesday, August 25, 2021 at 4:30 p.m. Eastern Time (ET) to review its second quarter 2021 financial results and provide a business update.

Conference Call Details

A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at http://www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

About Ascendis Pharma A/S

Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies.

Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs.

Ascendis is headquartered in Copenhagen, Denmark, with additional facilities in Heidelberg and Berlin, Germany, in Palo Alto and Redwood City, California, and in Princeton, New Jersey.

Please visit http://www.ascendispharma.com (for global information) or http://www.ascendispharma.us (for U.S. information).

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ ability to apply its platform technology to build a leading, fully integrated biopharma company, (ii) Ascendis’ product pipeline and expansion into additional therapeutic areas and (iii) Ascendis’ expectations regarding its ability to utilize its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis’ ability to obtain additional funding, if needed, to support its business activities and the effects on its business from the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 10, 2021 and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma Group. August 2021 Ascendis Pharma A/S.

Investor contacts: Tim Lee Ascendis Pharma (650) 374-6343 tle@ascendispharma.com

Patti Bank Westwicke Partners (415) 513-1284 patti.bank@westwicke.com ir@ascendispharma.com

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Ascendis Pharma A/S Announces Second Quarter 2021 Financial Results and Business Update Conference Call on August 25 - Stockhouse

Study: Biosimilar rhGH Well Tolerated and Effective in Turner Syndrome – The Center for Biosimilars

A multicenter observational study of 348 children with Turner syndrome (TS) found that biosimilar recombinant human growth hormone (rhGH) therapy was safe and effective in real-life clinical practice.

The investigators reported on a subgroup of patients with TS from the PAtients TReated with Omnitrope (PATRO) Children study, a long-term, postmarketing surveillance study of children treated with biosimilar rhGH (Omnitrope; Sandoz).

TS is characterized by partial or complete loss of the second sex chromosome in females and is associated with comorbidities, including growth failure. TS has been treated with reference rhGH (Genotropin; Pfizer) since its approval in 1995. The biosimilar Omnitrope became available after approval by the European Medicines Agency and the FDA in 2006.

The investigators enrolled 348 patients being treated for TS at 130 centers across Europe. Their mean age was 9.0 (range, 0.7-18.5) years at baseline. Most (81.6%) were rhGH nave, and 90.2% were prepubertal. The mean (SD) treatment duration in the study was 38.5 (26.8) months.

No Unexpected Adverse Events

Safety was the primary end point of the study. The authors pointed out that rhGH is generally well tolerated in patients with TS; however, observational studies have reported greater risk for some adverse events (AEs) in patients with TS receiving rhGH. The AEs include intracranial hypertension, slipped capital femoral epiphyses, pancreatitis, and development or progression of scoliosis. The investigators wrote that their findings do not support an increased risk of these events due to rhGH therapy. However, noting the relatively short treatment duration in their study, they cautioned longer-term follow-up would be required to verify these safety findings.

Overall, approximately half of the patients (170; 48.9%) experienced AEs, most of which were mild or moderate. Twenty-five patients experienced treatment-related AEs, including headache, impaired glucose tolerance, increased insulin-like growth factor levels, and increased weight. One patient experienced scoliosis that was deemed treatment related.

Approximately half (172; 49.4%) of the patients discontinued the study. The most common reason (52 patients) for discontinuation was the attainment of adult height or bone age maturation. Six patients discontinued the study because of a lack of treatment response. Ten patients discontinued due to AEs, one of whom experienced a serious AE (intracranial hypertension) that was possibly related to treatment. The authors wrote that their safety findings show no evidence of an increased risk of developing unexpected AEs or new malignancies during rhGH treatment.

Substantial Height Gains

The investigators included 163 patients in their 3-year effectiveness cohort, 131 of whom were rhGH nave prior to the study. Most patients (98.5% of the rhGH-nave group and 90.6% of pretreated patients) were prepubertal.

Effectiveness was assessed by height velocity (HV), height standard deviation score (HSDS), and height velocity standard deviation score (HVSDS). The mean (SD) HV at 3 years was 5.2 (1.3) cm/year in prepubertal treatment-nave patients and 4.7 (1.4) cm/year in prepubertal pretreated patients. From baseline to 3 years, gains in HSDS were 1.17 in prepubertal treatment-nave patients and 0.04 in prepubertal pretreated patients. Mean increase in peak-centered HVSDS from baseline to 3 years was 3.94 in prepubertal rhGH-nave patients and 0.47 in prepubertal pretreated patients.

Adult height was reached by 51 patients (31.1%), 35 of whom were rhGH nave at baseline. In those 35 patients, the mean HSDS was 2.97 (1.03) at baseline, and at 3 years, the mean AHSDS was 2.02 (0.9). The AHSDS was similar in pretreated patients, at 2.10 (1.1).

These effectiveness findings are broadly in line with those from other observational studies in TS patients, according to the authors.

The authors concluded that treatment with biosimilar rhGH was well tolerated in patients with TS, and no unexpected safety signals were identified.

Several well-known AEs were observed, confirming the need for ongoing patient monitoring, they wrote. Although safety was their primary end point, they wrote that their effectiveness data showed substantial height gains were observed in prepubertal individuals over 3 years of treatment.

Reference

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The prevalence of inorganic mercury in human cells increases during aging but decreases in the very old | Scientific Reports – Nature.com

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The prevalence of inorganic mercury in human cells increases during aging but decreases in the very old | Scientific Reports - Nature.com