CLINICAL TRIALS PROFILE FOR TERIPARATIDE RECOMBINANT HUMAN

All Clinical Trials for Teriparatide Recombinant Human

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.
NCT00035256 ↗	Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis	Completed	Eli Lilly and Company	Phase 4	2001-10-01	The purpose of this study is to determine whether the increase in spine bone mineral density that has been generally observed in previous clinical studies involving the study drug can be maintained or even increased if followed with raloxifene HCl. All qualifying study participants will receive the study drug followed by treatment with raloxifene HCl or placebo. All study participants will receive raloxifene HCl in the third phase of the study.

Clinical Trial Conditions for Teriparatide Recombinant Human

Condition Name

Condition Name for Teriparatide Recombinant Human
Intervention	Trials
Osteoporosis	70
Osteoporosis, Postmenopausal	15
Postmenopausal Osteoporosis	11
Osteoporosis, Post-menopausal	5

Condition MeSH

Condition MeSH for Teriparatide Recombinant Human
Intervention	Trials
Osteoporosis	107
Osteoporosis, Postmenopausal	34
Fractures, Bone	19
Bone Diseases, Metabolic	8

Clinical Trial Locations for Teriparatide Recombinant Human

Trials by Country

Trials by Country for Teriparatide Recombinant Human
Location	Trials
United States	253
Canada	38
Denmark	14
Germany	12
Spain	12

Trials by US State

Trials by US State for Teriparatide Recombinant Human
Location	Trials
New York	22
Massachusetts	14
Georgia	13
Nebraska	13
Pennsylvania	13

Clinical Trial Progress for Teriparatide Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Teriparatide Recombinant Human
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for Teriparatide Recombinant Human
Clinical Trial Phase	Trials
Completed	96
Recruiting	20
Unknown status	11

Clinical Trial Sponsors for Teriparatide Recombinant Human

Sponsor Name

Sponsor Name for Teriparatide Recombinant Human
Sponsor	Trials
Eli Lilly and Company	51
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	9
Massachusetts General Hospital	8

Sponsor Type

Sponsor Type for Teriparatide Recombinant Human
Sponsor	Trials
Other	155
Industry	88
NIH	20

Clinical Trials Update, Market Analysis, and Projection for Teriparatide Recombinant Human

Last updated: October 29, 2025

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Introduction

Teriparatide recombinant human (brand names include Forteo and Forsteo) is a recombinant form of parathyroid hormone (PTH 1-34), primarily approved for the treatment of osteoporosis. Its anabolic mechanism stimulates osteoblast activity, promoting bone formation and increasing bone mineral density (BMD). With osteoporosis affecting an estimated 200 million people worldwide, especially postmenopausal women and the elderly, teriparatide remains a significant therapeutic agent. This report evaluates the current landscape of clinical trials, assesses market dynamics, and projects future industry trends for this drug.

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Clinical Trials Landscape

Regulatory History and Current Approved Uses

Teriparatide was first approved by the U.S. Food and Drug Administration (FDA) in 2002 for treatment of postmenopausal women with osteoporosis at high fracture risk, and subsequently for men with osteoporosis. Its approval by the European Medicines Agency (EMA) followed, with similar indications. The drug is prescribed for up to 24 months, given via daily subcutaneous injections.

Recent and Ongoing Clinical Trials

Recent years have seen a focus on expanding teriparatide’s application:

• Fracture Prevention in Glucocorticoid-Induced Osteoporosis: A Phase IV study ongoing in Europe assesses efficacy in corticosteroid-treated populations (EU Clinical Trials Register, NCT04382641).

• Combination Therapies: Several trials explore the synergy of teriparatide with anti-resorptive agents such as bisphosphonates, aiming to optimize bone density gains and fracture prevention.

• Duration and Safety Studies: Research examines the effects of extending therapy beyond 24 months, with some trials investigating the safety and efficacy of sequential therapy—initial teriparatide followed by antiresorptive agents—to sustain gains.

• Novel Indications: Preliminary investigations consider teriparatide in treating osteoporosis associated with chronic kidney disease (CKD), given the unmet need in this subgroup.

As of 2023, approximately 20 active clinical trials focus on diverse populations, with most concentrated in North America and Europe. These trials aim to refine dosing regimens, evaluate long-term safety, and assess quality of life improvements.

Regulatory and Research Challenges

Despite robust clinical evidence, the drug’s administration route (daily injections) remains a compliance challenge. Additionally, fears regarding osteosarcoma risk—raised in preclinical studies—prompt ongoing safety monitoring. The majority of investigations are designed to confirm long-term safety and expand indications.

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Market Analysis

Market Size and Dynamics

The global osteoporosis therapeutics market was valued at approximately USD 11 billion in 2022 and is projected to grow at a CAGR of 4.3% through 2030, driven by aging populations and increasing fracture prevalence [1].

Teriparatide occupies a significant niche within this space—estimated at USD 800-1 billion in annual sales pre-pandemic, primarily in North America and Europe. The United States accounted for nearly 70% of its revenue, reflecting high adoption rates driven by clinical guidelines and reimbursement policies.

Competitive Landscape

Key competitors include:

• Bisphosphonates (e.g., alendronate, zoledronic acid): First-line long-term agents. They have a cheaper profile but are less anabolic.
• Denosumab: A monoclonal antibody targeting RANKL, offering convenience with less frequent dosing.
• Romosozumab: A newer anabolic agent with dual effects—stimulating bone formation and reducing resorption, showing promise but with safety considerations.

While teriparatide is the most potent anabolic agent, its high cost (USD 800–1000/month) and injectable administration limit broader use.

Market Drivers

• Aging Demographics: The World Health Organization estimates that by 2050, the global population aged 60+ will reach over 2 billion, escalating osteoporosis prevalence.
• Chronic Disease Management: As awareness of osteoporosis increases, clinicians favor personalized treatment plans, often favoring teriparatide for severe cases.
• Reimbursement Policies: Insurance coverage in major markets continues to favor high-efficacy treatments despite higher costs.

Market Limitations

• Administration Route: Daily injections impair patient adherence.
• Safety Concerns: Osteosarcoma risk and hypercalcemia are advisories limiting prolonged use.
• Pricing: High drug costs restrain utilization, especially in emerging markets.

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Market Projections and Future Outlook

Growth Trends

The osteoporosis treatment market, particularly its anabolic segment, is projected to grow at a CAGR of approximately 5% over the next decade, supported by demographic trends and clinical innovations [2].

Innovation and Pipeline Development

The future of teriparatide hinges on:

• New Formulations: Development of weekly or monthly formulations, such as implantable devices or longer-acting analogs, to enhance compliance.
• Combination Therapies: Studies suggest benefits in sequential therapy—using teriparatide initially, followed by antiresorptives—to optimize fracture risk reduction.
• Extended Use and New Indications: Trials exploring beyond 24 months and use in osteoporosis secondary to other conditions (CKD, rheumatoid arthritis) may broaden its market.

Market Share Outlook

• Increased Adoption in Emerging Markets: Middle Eastern, Asian, and Latin American countries increasingly incorporate osteoporosis treatment, expanding accreditation and reimbursement frameworks.
• Potential Biosimilars: While biosimilars for recombinant proteins like teriparatide are under development, regulatory challenges and patent statuses will influence market penetration.

Strategic Implications for Stakeholders

• Pharmaceutical Developers: Focus on innovative delivery systems and expanding indications.
• Clinicians: Balance safety, cost, and efficacy when prescribing.
• Payers: Navigation of high-cost therapies within sustainable reimbursement policies.

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Key Takeaways

• Clinical Landscape: Ongoing trials aim to expand teriparatide’s use, refine safety profiles, and improve patient adherence through longer-acting formulations.
• Market Dynamics: Despite competition and cost constraints, the anabolic segment remains lucrative, buoyed by demographic shifts and clinical preference for high-efficacy treatments.
• Future Trends: Innovations in administration, combination therapy, and indications will likely enhance market penetration. Regulatory and safety considerations remain critical.

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FAQs

Q1: What is the primary therapeutic advantage of teriparatide over bisphosphonates?
A: Teriparatide is an anabolic agent stimulating bone formation, leading to rapid increases in bone mineral density and reduction in fracture risk, especially in severe osteoporosis cases.

Q2: Are there ongoing efforts to develop longer-acting formulations of teriparatide?
A: Yes, clinical trials are investigating weekly or monthly formulations, including implantable devices, to improve adherence and convenience.

Q3: How significant is the risk of osteosarcoma associated with teriparatide?
A: Preclinical studies showed a slight increase in osteosarcoma risk in rodents. While rare in humans, current guidelines limit therapy to a maximum of 24 months, with ongoing safety monitoring.

Q4: What trends can potentially expand teriparatide’s market?
A: Extension to new indications such as glucocorticoid-induced osteoporosis, CKD-associated osteoporosis, and combination therapies may broaden its market.

Q5: How does the cost of teriparatide impact its marketability?
A: High costs limit accessibility and utilization, especially in cost-sensitive markets, prompting development of biosimilars and alternative delivery options.

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References

[1] Market Research Future, “Osteoporosis Drugs Market Forecast to 2030,” 2022.
[2] Grand View Research, “Osteoporosis Therapeutics Market Size, Share & Trends,” 2022.