CLINICAL TRIALS PROFILE FOR PROLIA

Biosimilar Clinical Trials for PROLIA

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

All Clinical Trials for PROLIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for PROLIA

Condition Name

Condition Name for PROLIA
Intervention	Trials
Osteoporosis	24
Postmenopausal Osteoporosis	10
Osteoporosis, Postmenopausal	7

Condition MeSH

Condition MeSH for PROLIA
Intervention	Trials
Osteoporosis	46
Osteoporosis, Postmenopausal	19
Breast Neoplasms	5

Clinical Trial Locations for PROLIA

Trials by Country

Trials by Country for PROLIA
Location	Trials
United States	42
China	27
Poland	22
Denmark	7
Hungary	7

Trials by US State

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

Clinical Trial Progress for PROLIA

Clinical Trial Phase

Clinical Trial Phase for PROLIA
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	3
PHASE1	3

Clinical Trial Status

Clinical Trial Status for PROLIA
Clinical Trial Phase	Trials
Recruiting	33
Completed	30
Active, not recruiting	7

Clinical Trial Sponsors for PROLIA

Sponsor Name

Sponsor Name for PROLIA
Sponsor	Trials
Amgen	14
Massachusetts General Hospital	5
Martin Blomberg Jensen	5

Sponsor Type

Sponsor Type for PROLIA
Sponsor	Trials
Other	86
Industry	42
NIH	6

Clinical Trials Update, Market Analysis, and Projection for Prolia (Denosumab)

Last updated: September 17, 2025

Introduction

Prolia (denosumab), a monoclonal antibody developed by Amgen Inc., is indicated primarily for the treatment of osteoporosis in postmenopausal women and men at high fracture risk, as well as bone loss associated with certain cancer therapies. Since its FDA approval in 2010, Prolia has secured a substantial market share within the bone metabolism disease therapeutics, driven by its unique mechanism of action targeting RANKL (Receptor Activator of Nuclear factor Kappa-Β Ligand). This report evaluates the latest clinical developments, analyzes current market dynamics, and projects future growth potential for Prolia.

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Clinical Trials Update

Recent Clinical Developments

Over the past 24 months, Prolia has undergone numerous clinical investigations to expand its indication portfolio and refine its safety profile:

• Fracture Prevention in Men with Osteoporosis: Multiple Phase IV studies have reaffirmed Prolia’s efficacy in reducing vertebral, non-vertebral, and hip fractures in men, prompting ongoing post-marketing surveillance (PMR) studies to assess long-term safety and adherence.

• Cancer-Related Bone Loss: Prolia remains integral in managing bone metastases and treatment-induced osteoporosis among patients with breast and prostate cancers. Recent trials, including the DENOSOMA Phase III study, demonstrated significant reductions in skeletal-related events (SREs) among these populations, reaffirming its role in oncologic support therapy.

• Novel Indication Trials: Investigational research is exploring Prolia’s potential in conditions like rheumatoid arthritis and glucocorticoid-induced osteoporosis. For example, a recent Phase II trial indicated improved bone mineral density (BMD) in rheumatoid arthritis patients on corticosteroids, although regulatory approval is pending.

Ongoing Research and Future Trials

Current development efforts focus on:

• Combination Therapies: Evaluating co-administration of Prolia with anabolic agents such as teriparatide to optimize fracture prevention.

• Extended Dosing Intervals: Trials assessing alternate dosing schedules aim to improve patient compliance without compromising efficacy.

• Safety Profiles in Special Populations: Studies targeting pediatric populations with bone fragility syndromes and individuals with renal impairment are underway, exploring safety and dosing parameters.

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Market Analysis

Current Market Landscape

The global osteoporosis treatment market, valued at approximately $13 billion in 2022, is dominated by bisphosphonates, but denosumab has emerged as a leading alternative due to its convenient subcutaneous administration and potent anti-resorptive effects.

• Market Penetration: Prolia holds an estimated market share of approximately 50% among injectable osteoporosis therapies in developed countries, with higher penetration in North America and Europe.

• Competitive Dynamics: Romosozumab (Amgen/UCB) and bisphosphonates (e.g., alendronate, zoledronic acid) constitute key competitors. However, clinical advantages such as rapid onset of action and reduced gastrointestinal side effects favor Prolia’s placement in treatment algorithms.

• Pricing and Reimbursement: Prolia's annual treatment cost ranges from $2,000 to $3,500, influenced by healthcare system reimbursement policies, impacting market access and patient adherence.

Market Drivers and Barriers

Drivers:

• Rising prevalence of osteoporosis among aging populations.
• Increased awareness of fracture risks.
• Regulatory approvals for expanded indications.

Barriers:

• Cost constraints in emerging markets.
• Concerns about adverse events, including osteonecrosis of the jaw and atypical femoral fractures.
• Patient adherence issues due to injection frequency (biannual dosing).

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Future Market Projection

Growth Forecast (2023–2030)

Based on current clinical and market trends, the global Prolia market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 8% through 2030.

Key factors underpinning this growth include:

• Aging Demographics: The global population aged 65 and above is expected to reach 1 billion by 2030, amplifying osteoporosis prevalence and demand for effective therapies.

• Regulatory Expansion: Anticipated approvals for use in male osteoporosis and metabolic bone diseases will broaden its patient base.

• Pipeline Advancements: Ongoing trials into combination therapy and new indications could lead to market expansion and increased prescribing.

• Increased Awareness and Screening: More proactive osteoporosis screening programs will facilitate earlier diagnosis and treatment, boosting demand for interventions like Prolia.

Regional Market Variations

• North America: Dominates due to high diagnosis rates, reimbursement frameworks, and physician familiarity.
• Europe: Expected to mirror North American growth with regional approval extensions.
• Asia-Pacific: Rapid demographic shifts and rising awareness position this region for accelerated growth, albeit tempered by cost and healthcare infrastructure challenges.

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Strategic Implications

• Market Entry Opportunities: Companies can leverage the expanding indications to introduce complementary dosing modalities, such as subcutaneous pens, to improve patient experience.

• Regulatory Strategy: Ongoing efficacy and safety data will be pivotal for securing approvals in new indications and regions.

• Competitive Positioning: Maintaining a safety profile advantage and demonstrating superior adherence will be critical in countering competition from newer agents like romosozumab.

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Key Takeaways

• Clinical progress confirms Prolia's efficacy in expanding its therapeutic scope, including potential new indications, though regulatory approvals continue to evolve.
• The market remains robust, driven by demographic shifts, higher awareness, and favorable reimbursement trends, particularly in North America and Europe.
• Projected growth at a CAGR of around 8% through 2030 reflects sustained demand, with significant contributions from emerging markets and expanded indications.
• Strategic focus should be on optimizing dosing regimens, broadening indications through rigorous clinical trials, and navigating regional regulatory landscapes.
• Continuous vigilance over safety concerns and adherence improvements will be central to maintaining market dominance.

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FAQs

1. What are the main advantages of Prolia over traditional bisphosphonates?
   Prolia is administered via subcutaneous injection twice a year, offering comparable or superior efficacy with a lower risk of gastrointestinal side effects, and less complex dosing schedules, enhancing patient adherence.

2. Are there any significant safety concerns associated with Prolia?
   While generally well tolerated, adverse events such as osteonecrosis of the jaw and atypical femoral fractures have been reported, particularly with long-term use. Ongoing surveillance aims to elucidate these risks further.

3. What is the potential for Prolia in treating male osteoporosis?
   Regulatory approvals in multiple regions support Prolia's use in men at high fracture risk, with clinical trials demonstrating substantial bone density improvements and fracture risk reduction.

4. How might emerging therapies impact Prolia’s market share?
   Newer agents like romosozumab, with anabolic effects and rapid fracture risk reduction, could challenge Prolia’s dominance, necessitating strategic positioning and combination therapy assessments.

5. What are the prospects for expanding Prolia’s indications?
   Clinical trials exploring its use in cancer metastases, rheumatoid arthritis, and glucocorticoid-induced osteoporosis suggest a promising avenue for broader applications, contingent on successful trial outcomes and regulatory approvals.

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References

[1] U.S. FDA. (2010). FDA approves Prolia to treat postmenopausal women with osteoporosis.
[2] Amgen Inc. Corporate Reports, 2022.
[3] MarketWatch. (2022). Osteoporosis therapeutics market analysis.
[4] ClinicalTrials.gov. Ongoing studies involving Prolia.
[5] IQVIA. (2023). Global osteoporosis drug market projections.