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Last Updated: March 25, 2025

CLINICAL TRIALS PROFILE FOR PROLIA


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Biosimilar Clinical Trials for PROLIA

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04934072 ↗ A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis Recruiting Fresenius Kabi SwissBioSim GmbH Phase 3 2021-07-05 The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks. At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period. For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.
NCT04591275 ↗ Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® . Recruiting Shanghai Biomabs Pharmaceutical Co., Ltd. Phase 3 2021-03-31 evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
NCT04664959 ↗ A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis Active, not recruiting Samsung Bioepis Co., Ltd. Phase 3 2020-11-26 This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
NCT03293108 ↗ Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women Active, not recruiting AryoGen Pharmed Co. Phase 3 2017-04-29 The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women. Postmenopausal women diagnosed with osteoporosis according to their Bone mineral density result (BMD), aged between 45 to 75 are included in this trial. This is a Phase III, randomized, two armed, double-blind, parallel, active-controlled,non-inferiority clinical trial. The eligible patients are randomized in a 1:1 ratio to receive Arylia or Prolia® subcutaneous injections, at the beginning of the trial and every 6 months at month 6 and 12, in an 18-month study period. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study. The primary objective of this study is to assess non-inferiority of test- Denosumab 60 mg (Arylia) to the reference Denosumab 60 mg (Prolia®) in terms of efficacy among osteoporotic postmenopausal women. The secondary objectives of this study are: To further compare efficacy of test- Denosumab 60 mg to reference Denosumab 60 mg; To assess the safety of test- Denosumab 60 mg compared to reference Denosumab 60 mg.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for PROLIA

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01358669 ↗ Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty Unknown status Amgen Phase 2 2011-12-14 Although hip replacement surgery is a successful way of dealing with the pain and immobility caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10 years. The main reason for this is the development periprosthetic osteolysis, that is, loss of bone around the site of the hip replacement. The osteolysis is thought to be due to the small particles of debris worn from the surfaces of the hip implant. These particles cause a reaction in the blood cells around the joint which in turn affects bone cells and leads to a loss of bone around the implant. The joint implant will then eventually become loose and unstable, a condition known as aseptic loosening. At present the only way to treat aseptic loosening is to have another operation to secure the hip joint, known as revision surgery. Revision surgery is not always successful and exposes the patient to the risk of major surgery. In this study we explore the potential for giving a medication (denosumab) that may prevent the loss of bone around the hip replacement implant. We will recruit patients who have been listed for revision surgery. One group of patients will be given a single dose of denosumab; another group will be given a placebo (dummy drug). At the time of the revision surgery a small sample of the bone from around the hip replacement will be taken and examined under the microscope. Comparisons will be made between the patients having the denosumab and those having placebo to find out whether the denosumab is having a beneficial effect on the bone surfaces. If successful, this study will lead to further studies to develop the use of denosumab to prevent aseptic loosening.
NCT01358669 ↗ Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty Unknown status University of Sheffield Phase 2 2011-12-14 Although hip replacement surgery is a successful way of dealing with the pain and immobility caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10 years. The main reason for this is the development periprosthetic osteolysis, that is, loss of bone around the site of the hip replacement. The osteolysis is thought to be due to the small particles of debris worn from the surfaces of the hip implant. These particles cause a reaction in the blood cells around the joint which in turn affects bone cells and leads to a loss of bone around the implant. The joint implant will then eventually become loose and unstable, a condition known as aseptic loosening. At present the only way to treat aseptic loosening is to have another operation to secure the hip joint, known as revision surgery. Revision surgery is not always successful and exposes the patient to the risk of major surgery. In this study we explore the potential for giving a medication (denosumab) that may prevent the loss of bone around the hip replacement implant. We will recruit patients who have been listed for revision surgery. One group of patients will be given a single dose of denosumab; another group will be given a placebo (dummy drug). At the time of the revision surgery a small sample of the bone from around the hip replacement will be taken and examined under the microscope. Comparisons will be made between the patients having the denosumab and those having placebo to find out whether the denosumab is having a beneficial effect on the bone surfaces. If successful, this study will lead to further studies to develop the use of denosumab to prevent aseptic loosening.
NCT01358669 ↗ Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty Unknown status Sheffield Teaching Hospitals NHS Foundation Trust Phase 2 2011-12-14 Although hip replacement surgery is a successful way of dealing with the pain and immobility caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10 years. The main reason for this is the development periprosthetic osteolysis, that is, loss of bone around the site of the hip replacement. The osteolysis is thought to be due to the small particles of debris worn from the surfaces of the hip implant. These particles cause a reaction in the blood cells around the joint which in turn affects bone cells and leads to a loss of bone around the implant. The joint implant will then eventually become loose and unstable, a condition known as aseptic loosening. At present the only way to treat aseptic loosening is to have another operation to secure the hip joint, known as revision surgery. Revision surgery is not always successful and exposes the patient to the risk of major surgery. In this study we explore the potential for giving a medication (denosumab) that may prevent the loss of bone around the hip replacement implant. We will recruit patients who have been listed for revision surgery. One group of patients will be given a single dose of denosumab; another group will be given a placebo (dummy drug). At the time of the revision surgery a small sample of the bone from around the hip replacement will be taken and examined under the microscope. Comparisons will be made between the patients having the denosumab and those having placebo to find out whether the denosumab is having a beneficial effect on the bone surfaces. If successful, this study will lead to further studies to develop the use of denosumab to prevent aseptic loosening.
NCT00043186 ↗ Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density Completed Amgen Phase 2 2002-05-01 To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for PROLIA

Condition Name

2210730-2024681012141618202224OsteoporosisPostmenopausal OsteoporosisOsteoporosis, PostmenopausalBreast Cancer[disabled in preview]
Condition Name for PROLIA
Intervention Trials
Osteoporosis 22
Postmenopausal Osteoporosis 10
Osteoporosis, Postmenopausal 7
Breast Cancer 3
[disabled in preview] 0
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Condition MeSH

4419540051015202530354045OsteoporosisOsteoporosis, PostmenopausalBreast NeoplasmsBone Diseases, Metabolic[disabled in preview]
Condition MeSH for PROLIA
Intervention Trials
Osteoporosis 44
Osteoporosis, Postmenopausal 19
Breast Neoplasms 5
Bone Diseases, Metabolic 4
[disabled in preview] 0
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Clinical Trial Locations for PROLIA

Trials by Country

+
Trials by Country for PROLIA
Location Trials
United States 42
Poland 22
China 8
Estonia 6
Hungary 6
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Trials by US State

+
Trials by US State for PROLIA
Location Trials
New York 12
Massachusetts 5
New Jersey 5
Texas 4
Pennsylvania 3
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Clinical Trial Progress for PROLIA

Clinical Trial Phase

38.1%22.2%36.5%002468101214161820222426Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for PROLIA
Clinical Trial Phase Trials
Phase 4 24
Phase 3 14
Phase 2 23
[disabled in preview] 2
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Clinical Trial Status

42.0%40.6%10.1%7.2%051015202530CompletedRecruitingActive, not recruiting[disabled in preview]
Clinical Trial Status for PROLIA
Clinical Trial Phase Trials
Completed 29
Recruiting 28
Active, not recruiting 7
[disabled in preview] 5
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Clinical Trial Sponsors for PROLIA

Sponsor Name

trials012345678910111213AmgenMassachusetts General HospitalKessler Institute for Rehabilitation[disabled in preview]
Sponsor Name for PROLIA
Sponsor Trials
Amgen 12
Massachusetts General Hospital 5
Kessler Institute for Rehabilitation 4
[disabled in preview] 3
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Sponsor Type

64.1%27.5%00102030405060708090OtherIndustryNIH[disabled in preview]
Sponsor Type for PROLIA
Sponsor Trials
Other 84
Industry 36
NIH 6
[disabled in preview] 5
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Clinical Trials, Market Analysis, and Projections for Prolia (Denosumab)

Introduction to Prolia

Prolia, or denosumab, is a monoclonal antibody developed by Amgen for the treatment of various bone-related disorders. It works by blocking the RANK ligand, a protein that activates osteoclasts, the cells responsible for bone breakdown. This mechanism helps in preventing bone loss and increasing bone mineral density (BMD)[2][4].

Clinical Trials and Efficacy

FREEDOM Study and Long-Term Data

The pivotal FREEDOM study and its open-label extension have provided extensive data on the efficacy and safety of Prolia. The study involved postmenopausal women with osteoporosis and showed that Prolia significantly increased BMD over five continuous years of treatment. Specifically, the study reported a 13.7% increase in lumbar spine BMD and a 7.0% increase in total hip BMD after five years of treatment[2].

Safety Profile

The long-term use of Prolia, up to 10 years, has been evaluated in clinical studies. These studies have shown a similar adverse event profile to the pivotal trials, with no significant differences in safety outcomes between younger patients and those aged 75 or older. Common adverse events include back pain, pain in extremity, musculoskeletal pain, and upper respiratory tract infections[1][2].

Specific Safety Concerns

Prolia has been associated with several specific safety concerns, including severe hypocalcemia, which led the FDA to add a boxed warning to the drug's label. Other notable adverse events include clinically significant hypersensitivity reactions, including anaphylaxis, and an increased risk of infections and malignancies, although these are relatively rare[1][4].

Market Analysis

Current Market Position

Prolia is a significant player in the osteoporosis market, holding about 17% market share, behind the market leader alendronate. The drug's unique mechanism of action and its approval for various indications, including postmenopausal osteoporosis, bone loss associated with hormone ablation in men with prostate cancer, and glucocorticoid-induced osteoporosis, contribute to its market presence[5].

Global Denosumab Market

The global denosumab market, dominated by Prolia, was valued at USD 2,892.17 million in 2022 and is projected to grow to USD 7,109.92 million by 2030, with a compound annual growth rate (CAGR) of 11.9%. This growth is driven by the increasing demand for effective treatments for bone-related disorders and the expanding indications for denosumab[3].

Market Projections and Trends

Growth Drivers

The growth of the denosumab market is driven by several factors, including the rising prevalence of osteoporosis and other bone-related disorders, the aging population, and the increasing awareness and diagnosis of these conditions. Additionally, the collaboration between Amgen and other pharmaceutical companies, such as GlaxoSmithKline, for the commercialization of Prolia in various regions, is expected to further boost market growth[2][3].

Competitive Landscape

The osteoporosis market is competitive, with Prolia facing competition from other treatments like alendronate. However, Prolia's unique mechanism and its approval for multiple indications give it a distinct position. The emergence of biosimilars could potentially impact the market share of Prolia, but the drug's established brand and clinical evidence are likely to maintain its market presence[5].

Biosimilar Pipeline

There are several biosimilars in the pipeline for denosumab, which could enter the market in the coming years. This competition may affect the pricing and market share of Prolia, but it is also expected to increase access to this effective treatment for more patients[5].

Economic Impact

Cost of Osteoporotic Fractures

The economic burden of osteoporotic fractures is significant. In Europe, the direct medical cost of these fractures is expected to rise from €31.7 billion in 2000 to €76.7 billion by 2050. In the U.S., the cost was estimated at $19 billion in 2005 and is projected to increase to approximately $25 billion by 2025. Effective treatments like Prolia can help reduce these costs by preventing fractures and improving bone health[2].

Administration and Adherence

Prolia is administered via injection every six months by a healthcare provider, which helps optimize adherence. This regimen ensures that patients visit their healthcare providers regularly for evaluation and follow-up, enhancing the overall management of their condition[5].

Regulatory and Commercial Collaborations

Prolia is approved in various regions, including the U.S. and the European Union, for multiple indications. Amgen has collaboration agreements with companies like GlaxoSmithKline and Daiichi-Sankyo for the commercialization of Prolia in different markets. These collaborations are crucial for expanding the drug's reach and ensuring its availability in diverse geographical areas[2].

Key Takeaways

  • Efficacy and Safety: Prolia has demonstrated significant efficacy in increasing BMD and reducing fracture risk, with a generally favorable long-term safety profile.
  • Market Position: Prolia holds a substantial market share in the osteoporosis treatment market, driven by its unique mechanism and multiple approved indications.
  • Market Growth: The global denosumab market is projected to grow significantly, driven by increasing demand and expanding indications.
  • Competitive Landscape: While facing competition from other treatments and potential biosimilars, Prolia's established brand and clinical evidence maintain its market presence.
  • Economic Impact: Effective treatments like Prolia can help reduce the economic burden of osteoporotic fractures.

Frequently Asked Questions

What is Prolia used for?

Prolia (denosumab) is used for the treatment of postmenopausal women with osteoporosis at high risk for fracture, men with osteoporosis, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer and women with breast cancer receiving aromatase inhibitor therapy[2][4].

How is Prolia administered?

Prolia is administered via injection every six months by a healthcare provider. This regimen helps optimize adherence and ensures regular follow-up evaluations[5].

What are the common side effects of Prolia?

Common side effects of Prolia include back pain, pain in extremity, musculoskeletal pain, and upper respiratory tract infections. Severe hypocalcemia and hypersensitivity reactions are also potential risks[1][4].

How does Prolia work?

Prolia works by blocking the RANK ligand, a protein that activates osteoclasts, thereby preventing bone breakdown and increasing bone mineral density[2][4].

What is the market outlook for Prolia?

The global denosumab market, dominated by Prolia, is projected to grow significantly, reaching USD 7,109.92 million by 2030, driven by increasing demand and expanding indications[3].

Cited Sources

  1. Prolia® (denosumab) - Safety, Efficacy, & Side Effects. Proliahcp.com.
  2. Prolia(R) (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment. Investors.amgen.com.
  3. Global Denosumab Market – Industry Trends and Forecast to 2030. Databridgemarketresearch.com.
  4. Prolia (denosumab): Drug Safety Communication - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia. FDA.gov.
  5. An Update of the Denosumab Biosimilar Pipeline. Biosimilarsrr.com.

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