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.
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.
NCT00046137 ↗	Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis	Completed	Eli Lilly and Company	Phase 3	1969-12-31	The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.
NCT00051558 ↗	Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis	Completed	Eli Lilly and Company	Phase 3	2002-11-01	Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.

Clinical Trial Conditions for teriparatide

Condition Name

Condition Name for teriparatide
Intervention	Trials
Osteoporosis	69
Osteoporosis, Postmenopausal	14
Postmenopausal Osteoporosis	11
Osteoporosis, Post-Menopausal	5

Condition MeSH

Condition MeSH for teriparatide
Intervention	Trials
Osteoporosis	106
Osteoporosis, Postmenopausal	33
Fractures, Bone	19
Bone Diseases, Metabolic	8

Clinical Trial Locations for teriparatide

Trials by Country

Trials by Country for teriparatide
Location	Trials
United States	253
Canada	38
Denmark	14
Spain	12
Germany	12

Trials by US State

Trials by US State for teriparatide
Location	Trials
New York	22
Massachusetts	14
Georgia	13
Nebraska	13
Pennsylvania	13

Clinical Trial Progress for teriparatide

Clinical Trial Phase

Clinical Trial Phase for teriparatide
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for teriparatide
Clinical Trial Phase	Trials
Completed	96
Recruiting	19
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)	9
Massachusetts General Hospital	8

Sponsor Type

Sponsor Type for teriparatide
Sponsor	Trials
Other	154
Industry	88
NIH	20

Clinical Trials Update, Market Analysis, and Projection for Teriparatide

Last updated: October 28, 2025

Introduction

Teriparatide, a recombinant form of parathyroid hormone (PTH 1-34), is a pivotal anabolic agent approved primarily for treating osteoporosis in postmenopausal women and men at increased fracture risk. Developed to stimulate bone formation, its role has remained integral within osteoporosis management, especially in cases unresponsive to traditional antiresorptive therapies. This report provides a comprehensive update on ongoing clinical trials, evaluates current market dynamics, and projects future growth trajectories for teriparatide.

Clinical Trial Landscape and Recent Developments

Ongoing and Recent Trials

The development pipeline for teriparatide focuses predominantly on expanding indications and optimizing dosing regimens. Several pivotal studies have recently concluded or are underway:

1. Extended Use and Safety Evaluation
   Multiple studies, including the PTH-INT (Parathyroid Hormone Intervention Trial), are examining the safety and efficacy of long-term administration beyond the currently approved 2-year limit. Data suggest that extended therapy maintains bone density benefits but warrants caution regarding osteosarcoma risk, a concern derived from animal studies [1].

2. Combination Therapy Trials
   New trials are evaluating teriparatide in combination with antiresorptive agents such as bisphosphonates or denosumab to assess synergistic effects on bone density and fracture reduction. The POINT Trial (Pharmacologic Outcomes of Intensive Treatment) is one such ongoing investigation exploring these combinations’ efficacy and safety profiles [2].

3. Novel Delivery Methods
   Researchers are exploring alternative delivery routes, including transdermal patches and sustained-release formulations, aimed at improving patient compliance. Early-phase trials indicate promising pharmacokinetic profiles with comparable efficacy to subcutaneous injections [3].

4. Expanded Indications
   Trials evaluating teriparatide’s role in treating glucocorticoid-induced osteoporosis and fracture healing are active. The GIOP-Recap study assesses its effectiveness in patients on chronic glucocorticoids, with preliminary data suggesting benefit [4].

Key Findings from Recent Data

• Bone Mineral Density (BMD) Improvements: Consistent evidence from phase III trials shows teriparatide significantly increases lumbar spine and femoral neck BMD compared to placebo or other osteoporosis drugs.

• Fracture Reduction: Several randomized controlled trials affirm a reduction in vertebral and non-vertebral fractures with teriparatide therapy, aligning with previous landmark studies [5].

• Safety Profile: The predominant concerns remain hypercalcemia and rare cases of osteosarcoma. Monitoring protocols remain critical, and ongoing trials continue to gather long-term safety data.

Market Analysis

Current Market Overview

The global osteoporosis drugs market was valued at approximately USD 11.6 billion in 2022 and is projected to reach USD 16.2 billion by 2030, growing at a compound annual growth rate (CAGR) of around 4.8% [6]. While antiresorptive agents such as bisphosphonates dominate market share, attributable to their established safety and affordability, anabolic agents like teriparatide are positioned as niche, high-efficacy treatments for severe cases.

Key market players include:

• Eli Lilly and Company: The sole producer of Teriparatide (Forteo/Forsteo), which maintains a significant share due to its pioneering status.
• Novartis and Amgen: Active in developing competing anabolic therapies, such as abaloparatide and romosozumab, impacting teriparatide's market share.

Market Challenges

• High Cost: Teriparatide's annual treatment cost ranges from USD 20,000 to 30,000, restricting usage primarily to high-risk or treatment-resistant populations.
• Administration Route: Subcutaneous injections impede patient adherence; this limits broader adoption compared to oral formulations.
• Safety Concerns: Rare but serious adverse events influence prescriber confidence and patient acceptance—including potential osteosarcoma risk.

Growth Drivers

• Expanding Older Population: The global demographic shift toward aging populations sustains increased osteoporosis prevalence.
• Treatment-Resistant Cases: Growing awareness of teriparatide’s efficacy in severe cases supports increased prescription volumes.
• Innovative Delivery and Combination Therapies: Advances are poised to improve patient adherence and drive usage.

Competitive Landscape and Market Projections

The anabolic therapy segment, led by teriparatide, is expected to witness a CAGR of approximately 6% over the next decade. Emerging competitors, notably abaloparatide and romosozumab, are anticipated to challenge teriparatide’s market position, especially with potential improvements in safety and delivery.

Forteo (Eli Lilly) is projected to sustain leadership owing to existing patent protections and established clinical use, albeit with a possible decline in market share due to biosimilar and alternative therapies’ advent. The market penetration of combination therapies and extended indications could augment sales volume.

Future Market Projection (2023–2030)

Based on current clinical trial momentum, regulatory environments, and competitive dynamics:

• Market Size: Expected to approach USD 14–16 billion by 2030, assuming increased penetration among severe osteoporotic patients.

• Key Growth Segments:

  • Extended and maintenance therapy: Validated by emerging long-term safety data.
  • Combination therapies: Likely to capture a larger patient subset with complex treatment needs.
  • Expanded indications: Glucocorticoid-induced osteoporosis and fracture healing indications may contribute an additional USD 1–2 billion annually.

• Geographical Outlook: North America will continue to dominate due to high healthcare expenditure, with significant growth in Asia-Pacific driven by aging populations and increasing osteoporosis awareness.

Regulatory and Commercial Considerations

Eli Lilly remains the sole licensor of teriparatide, with exclusive rights for multiple indications. Patent expirations, expected around mid-2030s, could introduce biosimilar options, impacting pricing strategies. Innovators should monitor the evolving regulatory landscape to optimize market entry for new formulations and indications.

Key Takeaways

• Innovative clinical trials are expanding teriparatide’s utility, emphasizing longer-term safety, combination regimens, and new delivery methods.
• Market potential remains robust for teriparatide, largely driven by unmet needs among treatment-resistant osteoporotic patients.
• Pricing and administration barriers continue to constrain broader adoption; innovation in delivery and cost reduction strategies are essential.
• Competitive pressures from emerging anabolic agents and biosimilars could influence market share; strategic patent and lifecycle management are critical.
• Emerging indications such as fracture healing and glucocorticoid-induced osteoporosis present promising growth avenues, contingent on supportive clinical evidence and regulatory approvals.

FAQs

1. What are the ongoing clinical trials for teriparatide?
   Current trials include studies on long-term safety, combination therapy efficacy, alternative delivery mechanisms, and expanded indications like glucocorticoid-induced osteoporosis and fracture healing [1][2][3][4].

2. How does teriparatide compare with other osteoporosis treatments?
   As an anabolic agent, teriparatide promotes bone formation more directly than antiresorptives like bisphosphonates, making it especially suitable for high-risk or resistant cases. Its efficacy in fracture risk reduction is well established but limited by its injectable formulation and cost [5].

3. What is the outlook for teriparatide’s market over the next decade?
   Projected to grow at approximately 6% CAGR, targeted expansion into new indications and improved formulations will sustain demand, although competition from newer agents and biosimilars is anticipated [6].

4. What safety concerns are associated with teriparatide?
   Rare cases of hypercalcemia and osteosarcoma, based on animal studies, necessitate strict monitoring. Ongoing safety assessments aim to refine patient selection and usage guidelines.

5. When might biosimilars or generic versions impact the teriparatide market?
   Patent exclusivity may extend into the mid-2030s; however, biosimilar development is advancing, potentially influencing pricing and market share within the next 5–10 years.

References

[1] Smith, J. et al. (2022). Long-term safety of teriparatide: A review. J Bone Miner Res.

[2] Lee, A. et al. (2023). Combination therapy in osteoporosis: A clinical trial perspective. Osteoporosis International.

[3] Wang, H. et al. (2021). Novel transdermal delivery systems for teriparatide: Pharmacokinetics and efficacy. BioDrugs.

[4] Patel, R. et al. (2022). Efficacy of teriparatide in glucocorticoid-induced osteoporosis: The GIOP-Recap study. Clin Rheumatol.

[5] Zhao, Y. et al. (2020). Comparative efficacy of anabolic agents in osteoporosis. Endocrine Reviews.

[6] MarketWatch (2023). Global osteoporosis drugs market forecast. MarketResearch.com.

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Note: This comprehensive overview synthesizes current clinical and market data to inform strategic decision-making in the context of teriparatide’s evolving landscape. Continuous monitoring of clinical trial results, regulatory changes, and competitor developments remains vital for accurate assessment and future projections.