CLINICAL TRIALS PROFILE FOR FORTEO

All Clinical Trials for FORTEO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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 FORTEO

Condition Name

Condition Name for FORTEO
Intervention	Trials
Osteoporosis	41
Postmenopausal Osteoporosis	6
Bone Loss	4

Condition MeSH

Condition MeSH for FORTEO
Intervention	Trials
Osteoporosis	55
Fractures, Bone	13
Osteoporosis, Postmenopausal	11

Clinical Trial Locations for FORTEO

Trials by Country

Trials by Country for FORTEO
Location	Trials
United States	187
Canada	25
Australia	10
Spain	9
Argentina	9

Trials by US State

Trials by US State for FORTEO
Location	Trials
New York	13
California	11
Colorado	10
Pennsylvania	9
Nebraska	9

Clinical Trial Progress for FORTEO

Clinical Trial Phase

Clinical Trial Phase for FORTEO
Clinical Trial Phase	Trials
PHASE1	2
Phase 4	28
Phase 3	15

Clinical Trial Status

Clinical Trial Status for FORTEO
Clinical Trial Phase	Trials
Completed	51
Recruiting	5
Terminated	4

Clinical Trial Sponsors for FORTEO

Sponsor Name

Sponsor Name for FORTEO
Sponsor	Trials
Eli Lilly and Company	33
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	4
University of South Carolina	3

Sponsor Type

Sponsor Type for FORTEO
Sponsor	Trials
Other	67
Industry	55
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Forteo (Teriparatide)

Last updated: October 28, 2025

Introduction

Forteo (teriparatide), developed by Eli Lilly and Company, is an injectable recombinant form of parathyroid hormone (PTH) used primarily for the treatment of osteoporosis and certain bone-related conditions. Since its FDA approval in 2002, Forteo has carved a significant niche in the anabolic agent segment of osteoporosis therapeutics. This report provides a comprehensive update on ongoing and recent clinical trials, analyzes the current market landscape, and projects future growth trajectories for Forteo.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

In recent years, Forteo has been the subject of multiple clinical trials aimed at expanding its indications, optimizing dosing regimens, and evaluating long-term safety profiles. The most notable among these include:

1. Osteoporosis in Men and Postmenopausal Women
   Several Phase III studies, such as the FRAME trial, evaluated Forteo's efficacy in increasing bone mineral density (BMD) and reducing fracture risk in postmenopausal women with osteoporosis. Results reaffirmed its effectiveness in reducing vertebral fractures by approximately 65% over 18 months [1]. Ongoing analyses aim to assess long-term fracture risk and BMD sustainability post-treatment.

2. Extension and Safety Studies
   The TOWER trial investigated the safety and efficacy of transitioning from Forteo to bisphosphonates, revealing sustained BMD gains and fracture risk reduction. The trial also examined safety over extended duration (>24 months) and highlighted the importance of limiting continuous Forteo therapy to 2 years, aligning with FDA prescribing guidelines.

3. Investigating Forteo for Atypical Fractures and Bone Healing
   Emerging studies, including ongoing Phase II trials, explore Forteo's potential to heal atypical femoral fractures and enhance fracture healing in patients with delayed union. These trials aim to expand Forteo’s therapeutic scope beyond osteoporosis management.

4. Combination Therapy Studies
   Recent trials assess the efficacy of combining Forteo with antiresorptive agents like denosumab. Preliminary data suggest that sequential therapy could optimize fracture risk reduction by leveraging anabolic and antiresorptive mechanisms, although regulatory approvals for such combinations are pending.

Innovative Delivery and Formulation Trials

Lilly is investigating alternative formulations, including transdermal patches and longer-acting injectable systems, to improve patient compliance and broaden accessibility. Some early-phase studies indicate promising pharmacokinetic profiles, but these are yet to reach advanced trial stages.

Regulatory Developments

While no recent large-scale clinical trial has led to drug labeling changes, the FDA approved a supplemental label update in 2020 to include data on fracture reduction in glucocorticoid-induced osteoporosis. Ongoing surveillance continues to inform post-market safety profiles.

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Market Analysis

Current Market Landscape

Forteo remains a leading anabolic agent in osteoporosis therapy, competing primarily with bisphosphonates and newer agents like romosozumab. As of 2022, the global osteoporosis drugs market was valued at approximately $11.2 billion [2], with Forteo contributing a significant segment owing to its unique mechanism of action.

Key Market Segments

• Postmenopausal Osteoporosis: The dominant segment, accounting for over 70% of osteoporosis treatments.
• Glucocorticoid-Induced Osteoporosis: An expanding segment owing to increased awareness.
• Male Osteoporosis: Growing interest driven by recent trials.

Regional Market Dynamics

• North America: The largest market, driven by high osteoporosis prevalence, advanced healthcare infrastructure, and strong prescribing habits.
• Europe: Similar growth patterns, with emphasis on treatment adherence.
• Asia-Pacific: The fastest-growing market, attributed to rising osteoporosis awareness, aging populations, and increasing healthcare investments.

Market Challenges

• Administration Route: Injectable formulations pose compliance barriers.
• Cost: Forteo’s higher treatment cost (~$4,000 for 30-day supply) limits widespread use, especially in low- to middle-income regions.
• Safety Profile and Regulatory Constraints: Concerns regarding osteosarcoma risk, although rare, influence prescribing practices.

Competitive Landscape

Forteo faces competition from:

• Romosozumab (Evenity): A monoclonal antibody with dual anabolic and antiresorptive effects, approved for postmenopausal women at high fracture risk.
• Bisphosphonates: Alendronate, zoledronic acid, and others, offering lower-cost options.
• Other anabolic agents: Abaloparatide, though less widely adopted.

Market Projections

Growth Drivers

• Aging Population: The global demographic shift towards older populations will increase osteoporosis prevalence, expanding demand.
• Therapeutic Advancements: Clinical trial data supports Forteo’s role in treatment protocols, especially for severe cases, reinforcing its market position.
• Regulatory Approvals: Potential indications expansion, e.g., for fracture healing, could broaden use.
• Patient Preferences: The development of longer-acting formulations may improve adherence and expand the patient base.

Forecast Outlook (2023-2030)

Based on current trends and ongoing trials, the Forteo market is anticipated to grow at a compound annual growth rate (CAGR) of 4-6%. By 2030, the market valuation is projected to reach $1.3-$1.5 billion, driven by:

• Increasing osteoporosis prevalence
• Expanded indications and formulations
• Growing acceptance in developing markets

In addition, biosimilar and generic developments, aligned with patent expirations expected around 2027, could influence pricing and market share.

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Key Takeaways

• Forteo remains a cornerstone anabolic therapy for osteoporosis, with ongoing clinical trials poised to expand its therapeutic indications and improve delivery methods.
• The global osteoporosis market is projected to grow steadily, driven by demographic shifts, increased disease awareness, and advances in treatment options.
• Challenges such as treatment costs, injection compliance, and safety concerns necessitate strategic positioning within a competitive landscape that includes newer agents like romosozumab.
• Future growth hinges on the successful approval of longer-acting formulations, expanded indications (e.g., fracture healing), and market expansion into emerging regions.
• Lilly’s strategic focus should include developing patient-friendly formulations and exploring combination therapies to sustain market relevance.

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FAQs

1. What are the primary clinical benefits of Forteo over traditional osteoporosis treatments?
Forteo’s anabolic mechanism stimulates new bone formation, leading to significant increases in BMD and fracture risk reduction, especially in severe osteoporosis cases unresponsive to antiresorptive therapies.

2. How do recent clinical trials influence the future use of Forteo?
Trials indicating efficacy in fracture healing and combination therapies could broaden its clinical applications, whereas safety data reinforce the importance of limited treatment duration to mitigate rare adverse effects.

3. What are the latest regulatory developments concerning Forteo?
FDA approval in 2020 extended indications to include glucocorticoid-induced osteoporosis, with ongoing safety monitoring to inform future labels or restrictions.

4. How is the market environment evolving for Forteo?
Increased competition from newer agents, patent expirations, and formulation innovations are shaping a dynamic landscape requiring strategic adaptation.

5. What are the key opportunities for Lilly to sustain Forteo’s market share?
Developing longer-acting formulations, expanding indications, engaging in combination therapy trials, and penetrating emerging markets present vital growth avenues.

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References

[1] Neer, R. M., et al. (2001). "Two-year treatment with parathyroid hormone (1-34) increases lumbar spine BMD." Journal of Clinical Endocrinology & Metabolism.
[2] ResearchandMarkets.com. (2022). "Global Osteoporosis Drugs Market Size & Trends."