CLINICAL TRIALS PROFILE FOR FORTEO

All Clinical Trials for FORTEO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00062595 ↗	Vitamin K and Bone Turnover in Postmenopausal Women	Completed	Eisai Co., Ltd.	Phase 3	2000-09-01	This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible: alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.
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 FORTEO

Condition Name

Condition Name for FORTEO
Intervention	Trials
Osteoporosis	39
Postmenopausal Osteoporosis	6
Bone Loss	4
Spinal Cord Injury	3

Condition MeSH

Condition MeSH for FORTEO
Intervention	Trials
Osteoporosis	53
Fractures, Bone	12
Osteoporosis, Postmenopausal	11
Hip Fractures	4

Clinical Trial Locations for FORTEO

Trials by Country

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

Trials by US State

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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
Phase 4	28
Phase 3	15
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FORTEO
Clinical Trial Phase	Trials
Completed	50
Recruiting	5
Unknown status	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	53
NIH	8

Clinical Trials, Market Analysis, and Projections for Forteo (Teriparatide)

Introduction to Forteo

Forteo, also known as teriparatide, is a recombinant form of parathyroid hormone (PTH) used primarily for the treatment of osteoporosis. It is the first anabolic agent approved for the treatment of osteoporosis, distinguishing itself from other treatments that focus on inhibiting bone resorption.

Clinical Trials and Efficacy

Osteoporosis Treatment

Forteo has been extensively studied in clinical trials for its efficacy in treating osteoporosis. A key study published in the Journal of Bone and Mineral Research demonstrated that Forteo significantly increased lumbar spine volumetric bone mineral density (vBMD) in men with glucocorticoid-induced osteoporosis, outperforming risedronate in several metrics. The study showed a mean change from baseline of 16.3% for Forteo versus 3.8% for risedronate after 18 months[3].

Bone Density and Fracture Risk

In postmenopausal women, Forteo has been shown to increase bone density and reduce the incidence of fractures. A large placebo-controlled trial found that Forteo increased bone mass significantly, reduced new vertebral fractures by more than half, and caused minimal side effects. The trial indicated that 96% of patients treated with Forteo had an increase in bone mass, with 44% experiencing an increase greater than 10%[4].

Safety Profile

Despite its efficacy, Forteo's safety profile has been a subject of scrutiny, particularly regarding the risk of osteosarcoma. However, extensive studies, including those in Fischer 344 rats and human data, have shown no significant risk of osteosarcoma in patients treated with Forteo. The FDA has approved Forteo with a black box warning based on animal studies, but human data have not supported these concerns[4].

Market Analysis

Current Market Status

The global osteoporosis treatment market, in which Forteo is a key player, is estimated to be worth around USD 12.79 billion in 2024. This market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5% to reach approximately USD 19.84 billion by 2033[5].

Market Segmentation

The osteoporosis treatment market is segmented by drug class, among other factors. Forteo, as a recombinant PTH, falls under the anabolic agents category, which is gaining traction due to its unique mechanism of action that stimulates bone formation rather than just inhibiting bone resorption.

Regional Market

North America is the largest market for osteoporosis treatments, including Forteo. The region's dominance is attributed to high healthcare spending, advanced medical infrastructure, and a larger patient population suffering from osteoporosis[5].

Market Projections

Growth Drivers

The growth of the osteoporosis treatment market, and consequently Forteo's market share, is driven by several factors:

• Increasing Prevalence of Osteoporosis: The rising number of patients suffering from osteoporosis due to aging populations and other risk factors.
• Advancements in Treatment: Continuous research and development in osteoporosis treatments, including the approval of generic versions of teriparatide, are expected to boost the market.
• Regulatory Approvals: Recent and upcoming approvals of new treatments, such as the generic version of Forteo developed by Ambio and Teva, are expected to expand market access[5].

Competitive Landscape

Forteo faces competition from other osteoporosis treatments, including bisphosphonates, selective estrogen receptor modulators (SERMs), and calcitonin. However, its unique anabolic mechanism sets it apart, making it a preferred option for patients at high risk of fractures. New treatments like eneboparatide and Yorvipath, currently in clinical trials, may also impact the market dynamics in the future[1][4].

Future Outlook

Emerging Treatments

While Forteo remains a cornerstone in osteoporosis treatment, new treatments are on the horizon. For instance, the CALYPSO trial is testing eneboparatide, another PTH analog, for its safety and efficacy in patients with low or absent parathyroid hormone levels. Additionally, Yorvipath (PTH1-34) by Ascendis Pharma has been approved by the MHRA in the UK and is awaiting NICE approval, which could further diversify the treatment options available[1].

Generic Versions

The approval of generic versions of teriparatide is expected to increase market competition and potentially reduce costs, making Forteo more accessible to a broader patient population. This could lead to increased market share and revenue growth for Forteo and its generic counterparts[5].

Key Takeaways

• Clinical Efficacy: Forteo has been proven to significantly increase bone density and reduce fracture risk in various patient populations.
• Safety Profile: Despite initial concerns, extensive studies have shown no significant risk of osteosarcoma associated with Forteo.
• Market Growth: The osteoporosis treatment market is projected to grow at a CAGR of 5% to reach USD 19.84 billion by 2033.
• Competitive Landscape: Forteo's unique anabolic mechanism sets it apart, but new treatments and generic versions are expected to impact market dynamics.
• Future Outlook: Emerging treatments and generic versions are likely to expand treatment options and increase market access.

FAQs

What is Forteo used for?

Forteo, or teriparatide, is used for the treatment of osteoporosis in men and postmenopausal women who are at high risk for fractures.

How does Forteo work?

Forteo works by stimulating bone formation through its anabolic mechanism, which is distinct from other treatments that inhibit bone resorption.

What are the key benefits of Forteo?

Forteo significantly increases bone density, reduces the incidence of fractures, and has a minimal side effect profile compared to other treatments.

Are there any safety concerns associated with Forteo?

While initial animal studies raised concerns about the risk of osteosarcoma, extensive human data have shown no significant risk associated with Forteo.

What is the market outlook for Forteo?

The osteoporosis treatment market, including Forteo, is expected to grow at a CAGR of 5% to reach USD 19.84 billion by 2033, driven by increasing prevalence and advancements in treatment options.

Are there any new treatments emerging in the osteoporosis market?

Yes, new treatments such as eneboparatide and Yorvipath are currently in clinical trials and may soon be available, offering additional treatment options for patients.

Sources

1. Parathyroid UK: Current PTH clinical trials & treatments in the pipeline.
2. Research and Markets: Osteoporosis: Global Drug Forecast and Market Analysis to 2027.
3. PR Newswire: New Data on FORTEO® (teriparatide [rDNA origin] injection) Show Increased Bone Mineral Density in Men with Glucocorticoid-Induced Osteoporosis.
4. Cleveland Clinic Journal of Medicine: Recombinant human PTH 1-34 (Forteo): An anabolic drug for treating osteoporosis.
5. Precedence Research: Osteoporosis Treatment Market Forecast by 2033.