CLINICAL TRIALS PROFILE FOR PARATHYROID HORMONE

All Clinical Trials for parathyroid hormone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000427 ↗	Effects of Parathyroid Hormone in Men With Osteoporosis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1999-09-01	Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.
NCT00000427 ↗	Effects of Parathyroid Hormone in Men With Osteoporosis	Completed	Massachusetts General Hospital	Phase 3	1999-09-01	Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.
NCT00000400 ↗	Alendronate and/or Parathyroid Hormone for Osteoporosis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	1999-08-01	This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
NCT00000400 ↗	Alendronate and/or Parathyroid Hormone for Osteoporosis	Completed	Massachusetts General Hospital	Phase 2	1999-08-01	This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
NCT00000543 ↗	Oral Calcium in Pregnant Women With Hypertension	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1993-08-01	To determine of providing calcium supplementation to women with pre-existing hypertension reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of pre-eclampsia.

Clinical Trial Conditions for parathyroid hormone

Condition Name

Condition Name for parathyroid hormone
Intervention	Trials
Osteoporosis	40
Vitamin D Deficiency	34
Secondary Hyperparathyroidism	29
Chronic Kidney Disease	24

Condition MeSH

Condition MeSH for parathyroid hormone
Intervention	Trials
Hyperparathyroidism	66
Kidney Diseases	57
Renal Insufficiency, Chronic	56
Hyperparathyroidism, Secondary	48

Clinical Trial Locations for parathyroid hormone

Trials by Country

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Trials by Country for parathyroid hormone
Location	Trials
United States	556
Canada	40
China	27
Spain	24
Mexico	23

Trials by US State

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Trials by US State for parathyroid hormone
Location	Trials
New York	48
California	32
Texas	30
Pennsylvania	29
Illinois	29

Clinical Trial Progress for parathyroid hormone

Clinical Trial Phase

Clinical Trial Phase for parathyroid hormone
Clinical Trial Phase	Trials
Phase 4	70
Phase 3	60
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for parathyroid hormone
Clinical Trial Phase	Trials
Completed	184
Terminated	26
Recruiting	26

Clinical Trial Sponsors for parathyroid hormone

Sponsor Name

Sponsor Name for parathyroid hormone
Sponsor	Trials
Amgen	17
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	17
Shire	13

Sponsor Type

Sponsor Type for parathyroid hormone
Sponsor	Trials
Other	314
Industry	112
NIH	58

Parathyroid Hormone: Clinical Trials, Market Analysis, and Projections

Introduction to Parathyroid Hormone

Parathyroid hormone (PTH) is a crucial regulator of calcium and phosphate levels in the body. Its imbalance can lead to various health issues, including hypoparathyroidism and osteoporosis. The market for PTH treatments is evolving rapidly, driven by advancements in clinical trials, increasing demand, and innovative therapies.

Current Clinical Trials and Treatments in the Pipeline

Several clinical trials and treatments are currently underway to address the needs of patients with PTH-related disorders.

TransCon PTH

TransCon PTH, developed by Ascendis Pharma, is a once-daily, long-acting prodrug of parathyroid hormone (PTH[1-34]) designed to restore physiologic levels of PTH for 24 hours. The FDA extended the review period for TransCon PTH from May 14, 2024, to August 14, 2024, to evaluate the additional information provided in response to a Complete Response Letter (CRL)[1].

The safety and efficacy of TransCon PTH were evaluated in the phase 3 PaTHway trial and the phase 2 PaTH Forward trial. These trials showed promising results, with a significant proportion of patients achieving normal serum calcium levels and independence from conventional therapy[1].

Eneboparatide

Eneboparatide, being tested in the CALYPSO study by Amolyt Pharma, is another investigational medication aimed at treating patients with low or absent parathyroid hormone levels. This trial is the first PTH trial in the UK in many years and is focused on assessing the effects and safety of eneboparatide[4].

Yorvipath

Yorvipath (PTH1-34), also developed by Ascendis Pharma, has been approved by the MHRA for the treatment of chronic hypoparathyroidism in adults in the UK. However, it still awaits approval from NICE, which is expected to be finalized in early 2025[4].

Market Analysis

The parathyroid hormone market is experiencing robust growth driven by several key factors.

Market Size and Growth

The global parathyroid hormone market size is projected to grow significantly. In 2023, the market was valued at $2.35 billion and is expected to reach $2.43 billion in 2024. By 2028, the market is anticipated to grow to $3.5 billion at a compound annual growth rate (CAGR) of 9.6%[2][5].

Growth Drivers

Several factors are driving this growth:

• Increasing Prevalence of Chronic Kidney Disease: Rising cases of chronic kidney disease are contributing to the demand for PTH treatments.
• Growing Geriatric Population: The expanding geriatric population is a significant driver, as older adults are more prone to bone health issues.
• Expansion of Private Healthcare Sectors: Increased investment in healthcare infrastructure is improving access to PTH treatments.
• Emerging Indications and Precision Medicine: New indications and advancements in precision medicine are expanding the market.
• Growing Awareness of Bone Health: Heightened awareness of bone health is leading to increased demand for PTH treatments[2][3][5].

Regional Market Analysis

North America is projected to dominate the global parathyroid hormone market due to the high incidence rate of hypoparathyroidism, increased healthcare spending, and significant investments in research and development. Europe is expected to be the second-largest market, driven by a large geriatric population. The Asia Pacific region is likely to experience the highest CAGR due to economic growth and rising healthcare expenditure in developing countries[3].

Market Segmentation

The parathyroid hormone market can be segmented based on indication, end-user, and region.

Indication

The market can be classified into hypoparathyroidism, osteoporosis, and postmenopausal bone complications. Hypoparathyroidism is a key area of focus, with several new treatments in the pipeline[3].

End-User

The market is divided into hospitals, clinics, and others. Hospitals currently hold the major market share, but clinics are expected to expand at the highest CAGR due to improved medical services and favorable reimbursement scenarios[3].

Future Trends and Innovations

Several trends are expected to shape the future of the parathyroid hormone market:

Advancements in Drug Delivery Methods

Innovations in drug delivery, such as the development of long-acting prodrugs like TransCon PTH, are enhancing treatment efficacy and patient compliance[1].

Integration of Digital Health Technologies

The integration of digital health technologies is expected to improve patient monitoring, treatment adherence, and overall healthcare outcomes[5].

Development of Combination Therapies

Combination therapies that address multiple aspects of PTH-related disorders are being developed, offering more comprehensive treatment options[5].

Focus on Sustainability

The industry is also focusing on sustainability and green initiatives, which could influence the production and distribution of PTH treatments[5].

Key Takeaways

• Clinical Trials: Several promising clinical trials, including those for TransCon PTH and eneboparatide, are underway to address hypoparathyroidism and other PTH-related disorders.
• Market Growth: The global parathyroid hormone market is projected to grow to $3.5 billion by 2028 at a CAGR of 9.6%, driven by factors such as the growing geriatric population and increasing awareness of bone health.
• Regional Dominance: North America is expected to dominate the market, followed by Europe, with the Asia Pacific region experiencing the highest growth rate.
• Future Trends: Innovations in drug delivery, integration of digital health technologies, and a focus on sustainability are expected to shape the future of the market.

FAQs

What is the current status of TransCon PTH in the FDA review process?

The FDA has extended the review period for TransCon PTH from May 14, 2024, to August 14, 2024, to evaluate additional information provided in response to a Complete Response Letter (CRL)[1].

Which regions are expected to dominate the parathyroid hormone market?

North America is projected to dominate the market, followed by Europe, with the Asia Pacific region experiencing the highest growth rate[3].

What are the key drivers of the parathyroid hormone market growth?

Key drivers include the growing geriatric population, expansion of private healthcare sectors, emerging indications, precision medicine, and growing awareness of bone health[2][3][5].

What are some of the future trends expected in the parathyroid hormone market?

Future trends include advancements in drug delivery methods, integration of digital health technologies, development of combination therapies, and a focus on sustainability[5].

Are there any new treatments approved for hypoparathyroidism in the UK?

Yorvipath (PTH1-34) has been approved by the MHRA for the treatment of chronic hypoparathyroidism in adults in the UK, but it still awaits NICE approval[4].

Sources

1. FDA Extends Review Period for Hypoparathyroidism Treatment TransCon PTH. EMPR. May 15, 2024.
2. Global Parathyroid Hormone Market Size, Share And Growth Analysis For 2024-2033. EIN Presswire. August 6, 2024.
3. Parathyroid Hormone Market: Surge in R&D on the Development of Parathyroid Hormone Analogues to Drive the Market. BioSpace.
4. Current PTH clinical trials & treatments in the pipeline. Parathyroid UK.
5. Parathyroid Hormone Global Market Size & Competitors. Research and Markets.