CLINICAL TRIALS PROFILE FOR CALCITONIN HUMAN

All Clinical Trials for Calcitonin Human

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004358 ↗	Phase II Study of Calcitonin for Tumoral Calcinosis	Completed	Ann & Robert H Lurie Children's Hospital of Chicago	Phase 2	1992-11-01	OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.
NCT00004358 ↗	Phase II Study of Calcitonin for Tumoral Calcinosis	Completed	National Center for Research Resources (NCRR)	Phase 2	1992-11-01	OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.
NCT00005006 ↗	Parathyroid Hormone (PTH) With Alendronate for Osteoporosis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	1987-09-01	This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00005006 ↗	Parathyroid Hormone (PTH) With Alendronate for Osteoporosis	Completed	Helen Hayes Hospital	Phase 2	1987-09-01	This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00079378 ↗	Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1	2004-02-01	This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with refractory or relapsed acute myeloid leukemia or previously treated chronic lymphocytic leukemia or small lymphocytic leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining decitabine with valproic acid may kill more cancer cells.
NCT00084461 ↗	Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors	Terminated	National Cancer Institute (NCI)	Phase 2	2004-03-01	Phase II trial to study the effectiveness of romidepsin in treating patients who have locally advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Clinical Trial Conditions for Calcitonin Human

Condition Name

Condition Name for Calcitonin Human
Intervention	Trials
Migraine	21
Osteoporosis	6
Migraine Without Aura	5
Osteoarthritis	5

Condition MeSH

Condition MeSH for Calcitonin Human
Intervention	Trials
Migraine Disorders	36
Headache	16
Osteoporosis	14
Carcinoma, Neuroendocrine	10

Clinical Trial Locations for Calcitonin Human

Trials by Country

Trials by Country for Calcitonin Human
Location	Trials
United States	132
Denmark	29
Japan	25
China	17
United Kingdom	8

Trials by US State

Trials by US State for Calcitonin Human
Location	Trials
Missouri	12
Maryland	11
New York	10
California	10
Ohio	10

Clinical Trial Progress for Calcitonin Human

Clinical Trial Phase

Clinical Trial Phase for Calcitonin Human
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	15
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Calcitonin Human
Clinical Trial Phase	Trials
Completed	72
Recruiting	23
Unknown status	12

Clinical Trial Sponsors for Calcitonin Human

Sponsor Name

Sponsor Name for Calcitonin Human
Sponsor	Trials
Danish Headache Center	18
Novartis	13
National Cancer Institute (NCI)	10

Sponsor Type

Sponsor Type for Calcitonin Human
Sponsor	Trials
Other	124
Industry	54
NIH	16

Calcitonin Human: Clinical Trials, Market Analysis, and Projections

Introduction to Calcitonin

Calcitonin is a hormone produced by the thyroid gland that plays a crucial role in regulating calcium levels in the body. It is used therapeutically to treat conditions such as osteoporosis and hypercalcemia. Here, we will delve into recent clinical trials, market analysis, and future projections for human calcitonin.

Clinical Trials Update

LEADER Trial Findings

One of the significant clinical trials involving calcitonin is the LEADER trial, which focused on the effects of liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, on calcitonin levels. The trial involved 9,340 patients with type 2 diabetes and a high risk for cardiovascular events, randomized to either liraglutide or placebo over a 3.5-5 year period.

Key findings from the LEADER trial include:

• No evidence that liraglutide stimulates calcitonin release from human C-cells or causes C-cell proliferation or pathology[1].
• No significant differences in mean calcitonin concentrations between patients randomized to liraglutide and those to placebo in both male and female subgroups[1].
• Minor and comparable changes in calcitonin concentrations over time, with no indication of clinical significance[1].

Stabilized Form of Human Calcitonin

Researchers at Purdue University have developed a stabilized form of human calcitonin, aimed at improving its therapeutic potential. This new form involves phosphorylating specific amino acid residues to decrease the propensity for fibrillation, which reduces the efficacy of human calcitonin when used in aqueous solutions.

This innovation promises a safer and more effective treatment for osteoporosis, potentially replacing salmon calcitonin which has lower potency and more adverse side effects[4].

Market Analysis

Current Market Size and Growth

The global calcitonin market, including both synthetic and natural forms, is valued at USD 12.9 billion as of 2023 and is projected to reach USD 62.3 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 18.4% from 2023 to 2033[2].

Key Drivers of Market Growth

Several factors are driving the growth of the calcitonin market:

• Increasing Prevalence of Osteoporosis: The rising number of osteoporosis cases globally, particularly among the elderly population, is a significant driver. Over 200 million people worldwide suffer from osteoporosis, with women being more affected than men[5].
• Growing Elderly Population: The aging population worldwide is contributing to the increased incidence of bone-related disorders, which in turn boosts the demand for calcitonin-based treatments[2][5].
• Research and Development: Continuous research aimed at improving the effectiveness and safety of calcitonin-based treatments is also driving market growth[2].

Market Segmentation

The calcitonin market is segmented by geography and distribution channels:

• Geography: North America is currently the largest market, followed by Europe and Asia Pacific. The Asia Pacific region is expected to be the fastest-growing market due to increasing healthcare expenditure and awareness about preventive healthcare[2][5].
• Distribution Channels: The market is bifurcated into hospital pharmacies, retail pharmacies, and online pharmacies. Calcitonin is primarily distributed through hospital and retail pharmacies, with online pharmacies gaining traction[5].

Market Projections

Future Growth and Trends

The calcitonin market is expected to experience moderate to high growth in the coming years:

• Increasing Demand for Personalized Medicine: The trend towards personalized medicine and preventive healthcare is expected to further boost the demand for calcitonin-based treatments[2].
• Advancements in Treatment Forms: Innovations like the stabilized form of human calcitonin developed by Purdue University are expected to increase the therapeutic potential and safety of calcitonin treatments, potentially replacing less effective forms like salmon calcitonin[4].

Regional Market Outlook

• Asia Pacific: This region is anticipated to be the fastest-growing market due to the increasing prevalence of osteoporosis and other bone-related disorders in countries like China and India. Factors such as increasing healthcare expenditure, growing awareness about preventive healthcare, and the availability of advanced medical technologies are driving this growth[2][5].
• North America and Europe: These regions will continue to be significant markets due to their established healthcare systems and high awareness about osteoporosis and other bone disorders[2].

Challenges and Limitations

Despite the positive outlook, there are several challenges and limitations:

• Adverse Effects: Prolonged use of calcitonin, particularly salmon calcitonin, has been associated with an increased risk of cancer, which has led to regulatory recommendations limiting its use to short durations[5].
• Lack of Awareness: In rural areas, there is a lack of awareness about osteoporosis and other bone disorders, which hinders the growth of the calcitonin market[5].

Key Takeaways

• Clinical Trials: Recent trials, such as the LEADER trial, have shown no adverse effects of liraglutide on calcitonin levels, and innovations like the stabilized form of human calcitonin are promising.
• Market Growth: The calcitonin market is expected to grow significantly, driven by the increasing prevalence of osteoporosis, growing elderly population, and advancements in treatment forms.
• Regional Outlook: Asia Pacific is expected to be the fastest-growing market, while North America and Europe will remain significant.
• Challenges: Adverse effects associated with prolonged use and lack of awareness in rural areas are key challenges.

FAQs

What is the current market size of the global calcitonin market?

The global calcitonin market is valued at USD 12.9 billion as of 2023[2].

What is the projected growth rate of the calcitonin market?

The calcitonin market is expected to grow at a CAGR of 18.4% from 2023 to 2033[2].

What are the main drivers of the calcitonin market growth?

The main drivers include the increasing prevalence of osteoporosis, growing elderly population, and research and development aimed at improving treatment effectiveness and safety[2][5].

Which region is expected to be the fastest-growing market for calcitonin?

The Asia Pacific region is expected to be the fastest-growing market due to increasing healthcare expenditure and awareness about preventive healthcare[2][5].

What are the challenges associated with the use of calcitonin?

Challenges include adverse effects associated with prolonged use, particularly the risk of cancer, and a lack of awareness about osteoporosis in rural areas[5].

Sources

1. No Evidence of Increase in Calcitonin Concentrations or C-Cell Pathology in Patients with Type 2 Diabetes Treated with Liraglutide: A Post Hoc Analysis of the LEADER Trial. Diabetes Care, 41(3), 620-628.
2. Calcitonin Market Predicted to Garner USD 62.3 Bn in 2033 | CAGR of 18.4%. EIN Presswire.
3. Migraine market continues exponential growth. IQVIA.
4. New drug form may help treat osteoporosis, calcium-related disorders. Purdue University Newsroom.
5. Calcitonin Salmon Market Size, Trends, Growth, Analysis, Forecast. Verified Market Research.