CLINICAL TRIALS PROFILE FOR PAMIDRONATE DISODIUM

All Clinical Trials for Pamidronate Disodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004088 ↗	Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 2	1999-04-13	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III multiple myeloma.
NCT00004088 ↗	Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma	Completed	City of Hope Medical Center	Phase 2	1999-04-13	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III multiple myeloma.
NCT00004906 ↗	Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1999-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer.
NCT00004906 ↗	Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer	Completed	Hackensack Meridian Health	Phase 2	1999-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer.
NCT00004906 ↗	Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer	Completed	Hackensack University Medical Center	Phase 2	1999-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer.
NCT00033332 ↗	Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 3	2002-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma. PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

Clinical Trial Conditions for Pamidronate Disodium

Condition Name

Condition Name for Pamidronate Disodium
Intervention	Trials
Multiple Myeloma and Plasma Cell Neoplasm	3
Bone Disease, Metabolic	1
Breast Cancer	1
Femoral Head Avascular Necrosis	1

Condition MeSH

Condition MeSH for Pamidronate Disodium
Intervention	Trials
Neoplasms, Plasma Cell	4
Multiple Myeloma	4
Plasmacytoma	3
Bone Diseases, Metabolic	1

Clinical Trial Locations for Pamidronate Disodium

Trials by Country

Trials by Country for Pamidronate Disodium
Location	Trials
United States	36
South Africa	1
Puerto Rico	1
Canada	1
Spain	1

Trials by US State

Trials by US State for Pamidronate Disodium
Location	Trials
California	3
Minnesota	2
Pennsylvania	2
Ohio	2
New Jersey	2

Clinical Trial Progress for Pamidronate Disodium

Clinical Trial Phase

Clinical Trial Phase for Pamidronate Disodium
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Pamidronate Disodium
Clinical Trial Phase	Trials
Completed	7
Terminated	1

Clinical Trial Sponsors for Pamidronate Disodium

Sponsor Name

Sponsor Name for Pamidronate Disodium
Sponsor	Trials
National Cancer Institute (NCI)	5
Hackensack University Medical Center	1
Mayo Clinic	1

Sponsor Type

Sponsor Type for Pamidronate Disodium
Sponsor	Trials
Other	7
NIH	5
Industry	1

Pamidronate Disodium: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Hypercalcemia of Malignancy

Pamidronate disodium has been extensively studied in clinical trials for its efficacy in treating hypercalcemia of malignancy. In one double-blind clinical trial, patients receiving 30 mg, 60 mg, or 90 mg of pamidronate disodium showed significant reductions in albumin-corrected serum calcium levels. By day 7, 40%, 61%, and 100% of patients in the respective dosage groups had normal-corrected serum calcium levels. The response was sustained, with many patients maintaining normal or partially reduced calcium levels at day 14[1].

Paget’s Disease of Bone

In patients with moderate to severe Paget’s disease, pamidronate disodium demonstrated significant efficacy. A clinical trial involving 64 patients treated with 15 mg, 45 mg, or 90 mg of pamidronate disodium over three consecutive days showed marked reductions in serum alkaline phosphatase and urine hydroxyproline/creatinine ratios. The 90 mg group had the most pronounced response, with 60% and 72% of patients showing a ≥50% decrease in these markers, respectively[1].

Bone Metastases and Skeletal-Related Events (SREs)

Pamidronate disodium is effective in reducing SREs in patients with bone metastases from cancers such as breast, prostate, and multiple myeloma. Clinical trials have shown that pamidronate disodium significantly delays the time to the first SRE, reduces the incidence of pathologic fractures, and decreases the need for radiation to bone. For example, in a study comparing pamidronate disodium to placebo, the pamidronate group had a lower skeletal morbidity rate and fewer pathologic fractures[1].

Pain Control in Metastatic Prostate Cancer

While pamidronate disodium has shown benefits in reducing SREs, its effect on pain control in metastatic prostate cancer is less clear. A combined analysis of two multicenter trials found no sustained significant differences in pain measurements or analgesic use between the pamidronate and placebo groups. However, urinary bone resorption markers were suppressed in the pamidronate group, suggesting some level of bone activity reduction[3].

Market Analysis

Market Size and Growth

The global pamidronate disodium market is projected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2034. The market is driven by the increasing prevalence of bone-related disorders such as osteoporosis and Paget’s disease, as well as rising cancer rates that necessitate treatments for hypercalcemia and bone complications[2].

Market Segmentation

The pamidronate disodium market is segmented by application, with the bone metastasis segment accounting for the largest share, approximately 44% in 2024. This segment is driven by the drug's critical role in treating cancer-related bone complications, including preventing fractures, managing hypercalcemia, and reducing SREs[2].

Regional Analysis

• North America: This region dominates the pamidronate disodium market, driven by high healthcare expenditure, advanced healthcare infrastructure, and the presence of key pharmaceutical companies. The United States is a major contributor due to robust R&D activities and high adoption rates of new therapies[2].
• Europe: Europe's market is driven by major pharmaceutical companies and a robust regulatory framework. Countries like Germany, the UK, and France lead the market, benefiting from significant investments in healthcare innovation and research[2].
• Asia Pacific: This region is expected to be the fastest-growing segment during the forecast period, driven by rapid economic growth, increasing healthcare expenditure, and expanding pharmaceutical manufacturing capacity. Countries like China, Japan, and India are at the forefront of this growth[2].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Bone Disorders: The rising prevalence of osteoporosis, Paget’s disease, and cancer-related bone complications drives the demand for pamidronate disodium.
• Improved Healthcare Infrastructure: Enhanced healthcare infrastructure, especially in underdeveloped countries, increases access to these treatments.
• Technological Advancements: Breakthroughs in medication delivery and supportive government regulations contribute to market growth[2].
• Early Diagnosis and Treatment: Improved diagnostic methods lead to earlier discovery and treatment, increasing demand for pamidronate disodium[2].

Challenges

• Side Effects and Adverse Reactions: Pamidronate disodium can cause side effects such as flu-like symptoms, low calcium levels, and injection site soreness. Renal impairment is a significant concern, and treatment must be withheld in patients with severe renal dysfunction[4].
• Competition from Other Bisphosphonates: The market for bisphosphonates is competitive, and other drugs may offer similar or better efficacy profiles, posing a challenge to pamidronate disodium's market share.

Key Market Players

The global pamidronate disodium market is dominated by a few large pharmaceutical companies, including:

• Novartis International AG
• Teva Pharmaceutical Industries Ltd.
• Mylan
• Sandoz These companies play a crucial role in driving market growth through their R&D activities, manufacturing capabilities, and distribution networks[2].

Projections and Future Outlook

Market Growth Projections

The pamidronate disodium market is anticipated to reach significant revenue by the end of the forecast period, driven by sustained growth rates. The market is expected to expand substantially from 2023 to 2031, with the Asia Pacific region emerging as the fastest-growing segment[5].

Emerging Trends

• Technological Innovations: Advances in drug delivery systems and supportive government regulations are expected to continue driving market growth.
• Increasing Healthcare Access: Improvements in healthcare infrastructure, particularly in underdeveloped countries, will increase access to pamidronate disodium treatments.
• Rising Cancer Rates: The increasing incidence of cancers that metastasize to the bone will continue to drive demand for pamidronate disodium[2].

"The global Pamidronate Disodium market is predicted to develop at a compound annual growth rate (CAGR) of xx% from 2024 to 2034, when it is projected to reach USD xx Million, based on an average growth pattern"[2].

Key Takeaways

• Clinical Efficacy: Pamidronate disodium is effective in treating hypercalcemia of malignancy, Paget’s disease, and reducing SREs in patients with bone metastases.
• Market Growth: The global market is projected to grow significantly, driven by increasing prevalence of bone disorders and improved healthcare infrastructure.
• Regional Dominance: North America currently dominates the market, but the Asia Pacific region is expected to be the fastest-growing segment.
• Key Players: Major pharmaceutical companies such as Novartis, Teva, Mylan, and Sandoz are key drivers of the market.
• Challenges: Side effects and competition from other bisphosphonates are significant challenges.

FAQs

What is pamidronate disodium used for?

Pamidronate disodium is used to treat hypercalcemia of malignancy, Paget’s disease of bone, and to minimize bone problems in diseases that have metastasized to the bones, including multiple myeloma and breast cancer. It can also be used to treat osteoporosis in specific circumstances[2].

What are the common side effects of pamidronate disodium?

Common side effects include flu-like symptoms, low calcium levels, and injection site soreness. Renal impairment is a significant concern, and treatment must be withheld in patients with severe renal dysfunction[4].

Which region dominates the pamidronate disodium market?

North America currently dominates the pamidronate disodium market due to high healthcare expenditure, advanced healthcare infrastructure, and the presence of key pharmaceutical companies[2].

What drives the growth of the pamidronate disodium market?

The market is driven by the increasing prevalence of bone-related disorders, improved healthcare infrastructure, technological advancements in medication delivery, and supportive government regulations[2].

Which companies are key players in the pamidronate disodium market?

Key players include Novartis International AG, Teva Pharmaceutical Industries Ltd., Mylan, and Sandoz[2].

Sources

1. PAMIDRONATE DISODIUM (pamidronate disodium) injection, solution - FDA Label.
2. Global Pamidronate Disodium Market Size, Scope & Forecast - We Market Research.
3. Combined analysis of two multicenter, randomized ... - PubMed.
4. pamidronate disodium injection | Pfizer Medical Information - US - Pfizer Medical Information.
5. Global Pamidronate Disodium For Injection Market Size, Scope And ... - Market Research Intellect.