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Last Updated: April 27, 2025

CLINICAL TRIALS PROFILE FOR ZOLEDRONIC ACID


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505(b)(2) Clinical Trials for zoledronic acid

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
OTC NCT00145275 ↗ To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women Completed Novartis Phase 3 2004-12-01 Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

All Clinical Trials for zoledronic acid

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00022087 ↗ Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer Completed National Cancer Institute (NCI) Phase 3 2001-12-01 RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss. PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.
NCT00022087 ↗ Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer Completed Alliance for Clinical Trials in Oncology Phase 3 2001-12-01 RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss. PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.
NCT00029224 ↗ Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions Completed Novartis Phase 4 2001-10-01 Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for zoledronic acid

Condition Name

5140270-50510152025303540455055OsteoporosisBreast CancerProstate Cancer[disabled in preview]
Condition Name for zoledronic acid
Intervention Trials
Osteoporosis 51
Breast Cancer 40
Prostate Cancer 27
[disabled in preview] 0
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Condition MeSH

745851001020304050607080OsteoporosisBreast NeoplasmsNeoplasm Metastasis[disabled in preview]
Condition MeSH for zoledronic acid
Intervention Trials
Osteoporosis 74
Breast Neoplasms 58
Neoplasm Metastasis 51
[disabled in preview] 0
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Clinical Trial Locations for zoledronic acid

Trials by Country

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Trials by Country for zoledronic acid
Location Trials
United States 854
United Kingdom 76
Canada 71
Germany 58
Australia 46
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Trials by US State

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Trials by US State for zoledronic acid
Location Trials
California 44
New York 40
Pennsylvania 37
Florida 32
Texas 29
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Clinical Trial Progress for zoledronic acid

Clinical Trial Phase

42.1%51.5%6.4%00102030405060708090Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for zoledronic acid
Clinical Trial Phase Trials
Phase 4 72
Phase 3 88
Phase 2/Phase 3 11
[disabled in preview] 0
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Clinical Trial Status

70.8%14.8%14.4%0020406080100120140160180CompletedTerminatedRecruiting[disabled in preview]
Clinical Trial Status for zoledronic acid
Clinical Trial Phase Trials
Completed 172
Terminated 36
Recruiting 35
[disabled in preview] 0
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Clinical Trial Sponsors for zoledronic acid

Sponsor Name

trials010203040506070Novartis PharmaceuticalsNovartisNational Cancer Institute (NCI)[disabled in preview]
Sponsor Name for zoledronic acid
Sponsor Trials
Novartis Pharmaceuticals 69
Novartis 48
National Cancer Institute (NCI) 22
[disabled in preview] 0
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Sponsor Type

58.8%34.4%6.8%0050100150200250300OtherIndustryNIH[disabled in preview]
Sponsor Type for zoledronic acid
Sponsor Trials
Other 303
Industry 177
NIH 35
[disabled in preview] 0
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Zoledronic Acid: Clinical Trials, Market Analysis, and Projections

Introduction

Zoledronic acid is a potent bisphosphonate used in the treatment of various bone-related disorders, including osteoporosis, Paget's disease, and bone complications associated with cancers. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials: Efficacy and Safety

Long-Term Efficacy in Prostate Cancer

A significant clinical trial highlighted the long-term efficacy of zoledronic acid in men with metastatic hormone-refractory prostate cancer. The study showed that 4 mg of zoledronic acid administered via a 15-minute infusion every 3 weeks for 15 months significantly reduced the incidence of skeletal-related events (SREs). Patients receiving zoledronic acid had a lower annual incidence of SREs (0.77 vs 1.47 for the placebo group) and a longer median time to the first SRE (488 days vs 321 days for the placebo group)[1].

Dosing Interval Comparison

Another crucial study compared the efficacy of zoledronic acid administered every 4 weeks versus every 12 weeks in patients with metastatic breast cancer, prostate cancer, or multiple myeloma. The results indicated that the longer dosing interval of every 12 weeks did not increase the risk of skeletal events over a 2-year period, suggesting that this regimen could be as effective as the standard 4-week interval while potentially reducing the frequency of administrations[4].

Market Analysis

Global Market Size and Growth

The global zoledronic acid market is anticipated to experience significant growth. By 2025, the market is expected to expand from its 2017 value, with a compound annual growth rate (CAGR) during the forecast period. The market is driven by increasing healthcare expenditure, government support for research and development, and a rise in the prevalence of cancer and osteoporosis[2][3].

Market Segmentation

The market is segmented by type (injection and powder) and application (Paget's disease, osteoporosis, and bone complications). The injection form is the most common and widely used, while the applications span across various bone-related conditions. The market is also analyzed by region, with North America, Europe, and Asia Pacific being key areas of focus[2][3].

Key Players and Competitive Landscape

Major players in the zoledronic acid market include Novartis, Teva Pharmaceutical, Pfizer, Hikma Pharmaceuticals, and several others. The market is characterized by a competitive landscape with multiple manufacturers, and the presence of substitutes like denosumab, alendronate, risedronate, and ibandronate poses a challenge[2][3][5].

Market Projections

Forecasted Market Size

By 2030, the global market for zoledronic acid solution is forecasted to reach US$ 351.7 million, growing at a CAGR of 5.3% from 2024 to 2030. This growth is driven by increasing demand for effective treatments for bone-related diseases and the expanding healthcare infrastructure[5].

Regional Growth

The market growth is expected to be robust across various regions, including North America, Europe, Asia Pacific, and other parts of the world. The Asia Pacific region, in particular, is anticipated to show significant growth due to the large patient population and increasing healthcare expenditure[2][3].

Challenges and Opportunities

Despite the positive growth projections, the market faces challenges from the presence of substitutes and the need for continuous research and development to maintain market share. However, opportunities arise from the trend towards personalized medicines, increased research activities, and collaborations for product development[3].

Key Takeaways

  • Clinical Efficacy: Zoledronic acid has been proven to reduce skeletal-related events in patients with metastatic cancers and other bone diseases.
  • Dosing Flexibility: The drug can be administered effectively at both 4-week and 12-week intervals, offering flexibility in treatment regimens.
  • Market Growth: The global market is expected to grow significantly, driven by increasing healthcare expenditure and the prevalence of bone-related diseases.
  • Competitive Landscape: The market is competitive with multiple key players, and the presence of substitutes poses a challenge.
  • Future Projections: The market is forecasted to reach US$ 351.7 million by 2030, with a CAGR of 5.3% from 2024 to 2030.

FAQs

What is the primary use of zoledronic acid?

Zoledronic acid is primarily used to prevent skeletal-related events (SREs) in patients with metastatic cancers, such as breast cancer, prostate cancer, and multiple myeloma, as well as for treating conditions like osteoporosis and Paget's disease.

What is the optimal dosing interval for zoledronic acid?

Clinical trials have shown that zoledronic acid can be effectively administered every 4 weeks or every 12 weeks without a significant difference in efficacy or toxicity, offering flexibility in treatment regimens[4].

Which regions are expected to drive the growth of the zoledronic acid market?

The Asia Pacific region, along with North America and Europe, is expected to drive the growth of the zoledronic acid market due to increasing healthcare expenditure and a large patient population[2][3].

What are the key drivers of the zoledronic acid market growth?

The market growth is driven by increasing healthcare expenditure, government support for research and development, and a rise in the prevalence of cancer and osteoporosis[2][3].

What challenges does the zoledronic acid market face?

The market faces challenges from the presence of substitutes like denosumab, alendronate, risedronate, and ibandronate, as well as the need for continuous research and development to maintain market share[3].

Sources

  1. Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal ... - Academic.oup.com
  2. Global Zoledronic Acid Market Insights, Forecast to 2025 - Radiantinsights.com
  3. Global Zoledronic Acid Market – Industry Trends and Forecast to 2028 - Databridgemarketresearch.com
  4. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on ... - Jamanetwork.com
  5. Zoledronic Acid Solution - Market Size - Valuates Reports - Reports.valuates.com

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