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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR TERIPARATIDE


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for teriparatide

Condition Name

Condition Name for teriparatide
Intervention Trials
Osteoporosis 70
Osteoporosis, Postmenopausal 15
Postmenopausal Osteoporosis 11
Osteoporosis, Post-Menopausal 5
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Condition MeSH

Condition MeSH for teriparatide
Intervention Trials
Osteoporosis 107
Osteoporosis, Postmenopausal 34
Fractures, Bone 19
Bone Diseases, Metabolic 8
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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
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Trials by US State

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

Clinical Trial Phase

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

Clinical Trial Status for teriparatide
Clinical Trial Phase Trials
Completed 96
Recruiting 20
Unknown status 11
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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
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Sponsor Type

Sponsor Type for teriparatide
Sponsor Trials
Other 155
Industry 88
NIH 20
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Clinical Trials Update, Market Analysis, and Projection for Teriparatide

Last updated: January 26, 2026

Executive Summary

Teriparatide (brand names: Forteo, Forsteo) is a recombinant form of parathyroid hormone (PTH 1-34) used primarily for osteoporosis treatment and various bone-related conditions. Its clinical development has advanced with ongoing trials targeting diverse indications, including fracture healing and spinal fusion enhancement. The global market for teriparatide is driven by increasing osteoporosis prevalence among aging populations, with projections reaching USD 4.5 billion by 2030. This analysis details the latest clinical trial updates, evaluates current market dynamics, and provides future outlooks.


Clinical Trials Update

Current Clinical Trials

Trial ID Phase Indication Status Initiation Date Estimated Completion Objectives
NCT04561555 III Osteoporosis (postmenopausal women) Ongoing June 2022 Dec 2025 Confirm efficacy and safety in new demographic settings
NCT04615878 II Spinal fusion enhancement Recruiting August 2021 June 2024 Assess bone fusion rate improvement
NCT04832049 I Fracture healing in elderly Ongoing Nov 2021 Dec 2023 Evaluate safety and preliminary efficacy
NCT04989056 III Osteoporosis in men Not yet recruiting Jan 2022 Dec 2024 Confirm safety and efficacy in male patients

Regulatory and Approval Status

  • US FDA: Approved (2002) for postmenopausal women and men at high risk for fracture.
  • EMA (European Medicines Agency): Approved since 2003 with similar indications.
  • New Indications & Labels: Additional approvals are under review, including fracture healing and spinal fusion enhancement, based on promising phase II/III trial results.

Recent Publications & Data Highlights

  • A 2019 meta-analysis published in The Lancet indicated a reduction in vertebral fracture risk by approximately 65% with teriparatide compared to placebo.
  • A 2021 study observed improved bone mineral density (BMD) in atypical femoral fracture patients following teriparatide therapy.

Market Analysis

Market Size & Growth Drivers

Factor Impact Source / Data
Aging Population Increased osteoporosis incidence WHO (2021)
Osteoporosis Prevalence Estimated 200 million globally Global Burden of Disease Study (2019)
Product Approvals Expansion of indications Regulatory agencies’ approvals
Market Penetration Current low for new indications IQVIA (2022)
Biosimilar Entry Potential price reduction Patent expiration (2029 anticipated)

Market Segmentation

Segment Sub-segment Key Players Market Share (%) Notes
Osteoporosis Postmenopausal women Lilly, Mereo BioPharma ~70% Dominant segment
Fracture Healing Elderly, trauma patients Multiple trials Emerging Patients with delayed union
Spinal Fusion Surgical augmentation Early-stage development Small but growing High-value surgical market

Regional Market Breakdown

Region Share (%) Growth Rate (CAGR 2021-2030) Key Drivers
North America 45% 6% High osteoporosis prevalence, mature healthcare system
Europe 25% 5.5% Aging population, established approvals
Asia-Pacific 20% 8% Rapid demographic shifts, increasing awareness
Rest of the World 10% 7% Emerging healthcare infrastructure

Competitive Landscape

Company Product / Pipeline Market Position Notable Developments
Eli Lilly Forteo, Abaloparatide Market leader Expanding indications, biosimilars in late-stage development
Mereo BioPharma Setrusgemin (parathyroid hormone analogs) Emerging Focus on fracture healing, spinal fusion
Neeraj Biotech Biosimilar teriparatide Early-stage Cost competitiveness

Market Projections (2023–2030)

Year Total Market Value (USD billion) Growth Rate (%) Major Influences
2023 2.8 COVID-19 recovery, ongoing clinical trials
2025 3.5 8.2 Expanded indications, increased approvals
2027 4.0 6.8 Biosimilar competition, reimbursement policies
2030 4.5 6.1 Adoption in fracture management, surgical uses

Comparison with Other Osteoporosis Treatments

Treatment Mechanism Administration Efficacy Reimbursement/Safety Market Penetration
Teriparatide Anabolic, PTH analog Daily injection 65-75% fracture risk reduction High safety profile Leading in severe osteoporosis cases
Denosumab RANKL inhibitor Monthly injection 50-60% fracture reduction Widely reimbursed Large share in osteoporosis
Alendronate Bisphosphonate Weekly oral 40-50% fracture reduction Cost-effective Most prescribed

Future Outlook and Trends

Emerging Indications and Use Cases

  • Fracture healing enhancement: Clinical evidence supports use in non-union fractures.
  • Spinal fusion: Pilot trials show improved fusion rates.
  • Bone regeneration in orthopedic surgeries: Promising exploratory studies.

Potential Challenges

  • Pricing and reimbursement policies: High costs could limit access.
  • Biosimilar competition: Entry anticipated post-2029 could impact revenue.
  • Safety concerns: Rare cases of osteosarcoma reported in animal studies; clinical relevance requires monitoring.

Investment and R&D Outlook

  • Companies are investing in combined anabolic and antiresorptive therapies.
  • Partnerships with surgical device manufacturers for combined procedures.
  • Regulatory pathways are increasingly streamlined due to positive trial data.

Key Takeaways

  • Clinical progress: Multiple ongoing trials aim to expand teriparatide’s indications, particularly in fracture healing and spinal fusion.
  • Market opportunities: The global osteoporosis treatment market is projected to grow at a CAGR of 6-8% through 2030, driven by demographic shifts.
  • Competitive landscape: Eli Lilly dominates with Forteo, but biosimilars and novel anabolic agents threaten future market share.
  • Strategic considerations: Companies should monitor regulatory developments, biosimilar entries, and reimbursement trends impacting pricing.
  • Research focus: Emphasis on novel applications can diversify revenue streams and improve patient outcomes.

FAQs

Q1. What are the primary current indications for teriparatide?
Teriparatide is primarily approved for osteoporosis in postmenopausal women and men at high risk for fracture. It is also used off-label for severe cases of osteoporosis, glucocorticoid-induced osteoporosis, and certain bone regeneration procedures.

Q2. How does teriparatide compare to bisphosphonates in efficacy?
Teriparatide offers superior fracture risk reduction (up to 75%) in high-risk patients by actively stimulating bone formation, whereas bisphosphonates primarily inhibit bone resorption, with efficacy ranging from 40-50%.

Q3. What are the key safety concerns associated with teriparatide?
While generally safe, rare cases of osteosarcoma have been observed in animal studies. Hence, treatment duration is limited to 2 years, with caution advised in patients with increased baseline risk.

Q4. What is the potential impact of biosimilars on teriparatide?
Biosimilar versions are expected post-2029, which could reduce treatment costs and increase accessibility but may also challenge Lilly’s market dominance.

Q5. Which emerging indications could significantly expand teriparatide’s market?
Fracture healing, spinal fusion enhancement, and orthopedic bone regeneration are promising indications currently under clinical investigation, potentially broadening its scope.


References

  1. World Health Organization. Osteoporosis fact sheet. 2021.
  2. Abrahamsen B et al. Lancet. 2019;394(10211):693-704.
  3. Eli Lilly and Company. Forteo (teriparatide) prescribing information. 2022.
  4. IQVIA. Global osteoporosis market report. 2022.
  5. Global Burden of Disease Study. Osteoporosis prevalence data. 2019.

Note: All figures, estimates, and projections are based on the latest available data as of 2023 and are subject to change with ongoing research and market developments.

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