CLINICAL TRIALS PROFILE FOR TERIPARATIDE

All Clinical Trials for TERIPARATIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for TERIPARATIDE

Condition Name

Condition Name for TERIPARATIDE
Intervention	Trials
Osteoporosis	67
Osteoporosis, Postmenopausal	13
Postmenopausal Osteoporosis	11
Osteoporosis, Post-menopausal	5

Condition MeSH

Condition MeSH for TERIPARATIDE
Intervention	Trials
Osteoporosis	103
Osteoporosis, Postmenopausal	32
Fractures, Bone	19
Bone Diseases, Metabolic	8

Clinical Trial Locations for TERIPARATIDE

Trials by Country

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Trials by Country for TERIPARATIDE
Location	Trials
United States	251
Canada	38
Denmark	14
Germany	12
Spain	12

Trials by US State

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Trials by US State for TERIPARATIDE
Location	Trials
New York	22
Pennsylvania	13
Massachusetts	13
Georgia	13
Nebraska	13

Clinical Trial Progress for TERIPARATIDE

Clinical Trial Phase

Clinical Trial Phase for TERIPARATIDE
Clinical Trial Phase	Trials
Phase 4	47
Phase 3	31
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for TERIPARATIDE
Clinical Trial Phase	Trials
Completed	95
Recruiting	17
Unknown status	11

Clinical Trial Sponsors for TERIPARATIDE

Sponsor Name

Sponsor Name for TERIPARATIDE
Sponsor	Trials
Eli Lilly and Company	51
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	8
Massachusetts General Hospital	7

Sponsor Type

Sponsor Type for TERIPARATIDE
Sponsor	Trials
Other	149
Industry	87
NIH	19

Teriparatide: Clinical Trials, Market Analysis, and Projections

Introduction to Teriparatide

Teriparatide, a synthetic form of the naturally occurring parathyroid hormone (PTH), is used primarily for the treatment of osteoporosis and, in some cases, hypoparathyroidism. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Approvals

Historical Context

Teriparatide, marketed as Forteo, was approved by the FDA in 2002 for the treatment of osteoporosis in patients at high risk for fracture. The approval was based on phase 3 trials, despite preclinical findings of osteosarcoma in rats treated with high doses of teriparatide[3].

Current and Ongoing Trials

While teriparatide itself is not in new clinical trials for osteoporosis, related research and new treatments are ongoing:

• YORVIPATH (Palopegteriparatide): Although not teriparatide, YORVIPATH is a prodrug of PTH(1-34) and has been approved by the FDA for the treatment of hypoparathyroidism in adults. This approval is significant as it reflects advancements in PTH analogs and their potential applications[1][4].

• CALYPSO Trial: This trial, conducted by Amolyt Pharma, is testing a new investigational medication called eneboparatide for people with low or absent parathyroid hormone levels. This trial is part of the ongoing research into PTH treatments and could provide insights into future therapeutic options[4].

Market Analysis

Osteoporosis Drugs Market

The osteoporosis drugs market, where teriparatide plays a significant role, is expected to grow substantially:

• Market Size: The market is estimated to reach USD 16.88 billion by 2025 and USD 21.28 billion by 2030, growing at a CAGR of 4.74% during the forecast period (2025-2030)[2][5].

• Geographical Distribution: North America is the largest market for osteoporosis drugs, while the Asia Pacific region is the fastest-growing market. This growth is driven by the increasing prevalence of osteoporosis, the growing geriatric population, and the need for effective treatment solutions[2][5].

• Segmentation: Bisphosphonates are the largest segment in the osteoporosis drugs market due to their effectiveness in reducing bone resorption. However, monoclonal antibodies like Denosumab and Romosozumab are the fastest-growing segment, offering advanced mechanisms of action with improved safety and efficacy profiles[5].

Product Launches and Approvals

Recent approvals and launches of innovative drugs are propelling market growth:

• Teriparatide Injection: In November 2023, Apotex Corp. launched a teriparatide injection in a pre-filled pen, designed for single-patient use to treat osteoporosis in the United States. This launch enhances the accessibility and convenience of teriparatide treatment[2].

• TYMLOS (Abaloparatide): Approved in December 2022, TYMLOS is a parathyroid hormone-related peptide analog used to increase bone mineral density among men with osteoporosis at high risk for fracture. This approval expands the treatment options available for osteoporosis patients[2].

Safety and Risk Mitigation

Osteosarcoma Risk

One of the significant concerns with teriparatide is the risk of osteosarcoma, a malignant bone tumor. Although preclinical studies in rats showed an increased incidence of osteosarcoma, real-world studies in humans have not identified a significant risk. The boxed warning regarding osteosarcoma was removed from the label in 2020 based on observational studies using real-world data[3].

Market Projections

Growth Drivers

The osteoporosis drugs market is driven by several key factors:

• Increasing Prevalence: The rising prevalence of osteoporosis, particularly among the geriatric population, is a major driver. For instance, the prevalence of osteoporosis in individuals aged 50 and over is estimated to be around 15.9%, with a significant gender disparity[2].

• Innovative Treatments: The launch and approval of new drugs, such as teriparatide injections and other PTH analogs, are expected to propel market growth. These innovations offer better efficacy and safety profiles, attracting more patients and healthcare providers[2][5].

• Emerging Markets: Expansion into emerging economies and developing countries is another growth opportunity. As healthcare infrastructure improves in these regions, the demand for osteoporosis treatments is expected to increase[5].

Key Takeaways

• Teriparatide remains a crucial treatment for osteoporosis, with ongoing research into related PTH analogs.
• Market Growth: The osteoporosis drugs market is expected to grow significantly, driven by increasing prevalence, innovative treatments, and expansion into emerging markets.
• Safety: While teriparatide has a historical association with osteosarcoma risk in preclinical studies, real-world data have not shown a significant risk in humans.
• New Treatments: Approvals and launches of new drugs like YORVIPATH and TYMLOS are enhancing treatment options for patients.

FAQs

Q: What is teriparatide used for?

A: Teriparatide is primarily used for the treatment of osteoporosis in patients at high risk for fracture. It is also being explored for other conditions, such as hypoparathyroidism.

Q: What are the risks associated with teriparatide?

A: One of the significant risks associated with teriparatide is the potential for osteosarcoma, although real-world studies have not shown a significant risk in humans.

Q: How is the osteoporosis drugs market expected to grow?

A: The osteoporosis drugs market is expected to grow at a CAGR of 4.74% from 2025 to 2030, reaching USD 21.28 billion by 2030.

Q: What are the fastest-growing segments in the osteoporosis drugs market?

A: Monoclonal antibodies, such as Denosumab and Romosozumab, are the fastest-growing segments due to their advanced mechanisms of action and improved safety and efficacy profiles.

Q: Are there new treatments being developed for hypoparathyroidism?

A: Yes, new treatments like YORVIPATH (palopegteriparatide) and eneboparatide are being developed and are in various stages of clinical trials and regulatory approvals.

Sources

1. FDA Approves YORVIPATH® (Palopegteriparatide) as the First and Only Treatment for Hypoparathyroidism in Adults. Ascendis Pharma.
2. Osteoporosis Drugs Market - Report, Growth & Research. Mordor Intelligence.
3. Teriparatide and osteosarcoma risk: History, science, elimination of boxed warning label updates. RTI International.
4. Current PTH clinical trials & treatments in the pipeline. Parathyroid UK.
5. Osteoporosis Drugs Market Share, Size & Growth 2025-2035. MetaTech Insights.