CLINICAL TRIALS PROFILE FOR AREDIA

All Clinical Trials for AREDIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124605 ↗	Arsenic Trioxide and Pamidronate in Treating Patients With Advanced Solid Tumors or Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 1	2005-04-01	Drugs used in chemotherapy, such as arsenic trioxide and pamidronate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide and pamidronate may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pamidronate may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together with pamidronate may kill more cancer cells. This phase I trial is studying the side effects and best dose of arsenic trioxide and pamidronate in treating patients with advanced solid tumors or multiple myeloma
NCT00128297 ↗	Pamidronate Administration in Breast Cancer Patients With Bone Metastases	Completed	Novartis	Phase 4	2000-10-18	The study objective is to evaluate the differences, in terms of first occurrence of a skeletal event, in patients with breast cancer and symptomatic bone metastases, when pamidronate is administered during 2 years, or when it is administered during 6 months, followed by a six month rest period, and again a 6 month treatment period.
NCT00062595 ↗	Vitamin K and Bone Turnover in Postmenopausal Women	Completed	Eisai Co., Ltd.	Phase 3	2000-09-01	This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible: alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.
NCT00062595 ↗	Vitamin K and Bone Turnover in Postmenopausal Women	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2000-09-01	This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible: alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.

Clinical Trial Conditions for AREDIA

Condition Name

Condition Name for AREDIA
Intervention	Trials
Breast Cancer	4
Osteoporosis	3
Osteopenia	2
Metastatic Bone Disease	1

Condition MeSH

Condition MeSH for AREDIA
Intervention	Trials
Breast Neoplasms	4
Bone Diseases, Metabolic	3
Osteoporosis	3
Neoplasms, Plasma Cell	2

Clinical Trial Locations for AREDIA

Trials by Country

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−

Trials by Country for AREDIA
Location	Trials
United States	8
Spain	2
Canada	1
France	1

Trials by US State

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−

Trials by US State for AREDIA
Location	Trials
Minnesota	2
Washington	1
Texas	1
Pennsylvania	1
New Mexico	1

Clinical Trial Progress for AREDIA

Clinical Trial Phase

Clinical Trial Phase for AREDIA
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for AREDIA
Clinical Trial Phase	Trials
Completed	9
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for AREDIA

Sponsor Name

Sponsor Name for AREDIA
Sponsor	Trials
Novartis	3
National Cancer Institute (NCI)	2
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for AREDIA
Sponsor	Trials
Other	12
Industry	7
NIH	3

Aredia: Clinical Trials, Market Analysis, and Projections

Introduction

Aredia, also known as pamidronate disodium, is a bisphosphonate drug that has been widely used in the treatment of various bone-related complications associated with cancer and other bone diseases. Here, we will delve into the clinical trials, market analysis, and future projections for Aredia.

Clinical Trials Overview

Multiple Myeloma

A pivotal clinical trial involving 392 patients with advanced multiple myeloma compared the efficacy of Aredia against a placebo. Patients received either 90 mg of Aredia or a placebo as a monthly 4-hour intravenous infusion for 9 months. The trial demonstrated that patients in the Aredia group had fewer skeletal-related events (SREs), such as pathologic fractures, radiation therapy to bone, surgery to bone, and spinal cord compression. The Aredia group also showed a lower skeletal morbidity rate and a longer time to the first SRE compared to the placebo group[1][3][4].

Hypercalcemia of Malignancy

Clinical trials have also shown Aredia's efficacy in treating hypercalcemia of malignancy. In one double-blind, randomized trial, patients receiving 90 mg of Aredia had significant reductions in serum calcium levels within 24 hours, with 100% of patients in the 90 mg group achieving normal-corrected serum calcium levels by day 7[4].

Paget's Disease

Aredia has been effective in treating Paget's disease of bone. A study involving 64 patients with moderate to severe Paget's disease showed that Aredia reduced serum alkaline phosphatase and urinary hydroxyproline levels significantly. The response was sustained, with some patients experiencing improvements even after the treatment was discontinued[3][4].

Breast Cancer

In breast cancer patients with osteolytic bone metastases, Aredia was compared to a placebo in two double-blind, randomized trials. The trials showed that Aredia reduced the incidence of SREs, such as pathologic fractures and the need for radiation therapy to bone, in patients receiving both chemotherapy and hormonal therapy[3][4].

Market Analysis

Current Market Position

Aredia has established itself as a key treatment option for bone-related complications in cancer patients, particularly those with multiple myeloma and breast cancer. Its approval for multiple indications, including hypercalcemia of malignancy, Paget's disease, and osteolytic bone metastases, has broadened its market reach.

Competitive Landscape

The bisphosphonate market is competitive, with other drugs like Zometa (zoledronic acid) and Fosamax (alendronate) also available. However, Aredia's specific indications and its proven efficacy in clinical trials have maintained its market share. The drug's ability to reduce skeletal-related events and improve quality of life for patients with advanced cancer has been a significant selling point.

Patient Population

Multiple myeloma, for instance, is the second most common hematologic malignancy in the United States, with approximately 12,500 new cases each year. Sixty percent of these patients are diagnosed at stage III, making Aredia a critical treatment option for managing skeletal complications[1].

Market Projections

Growth Drivers

• Increasing Incidence of Cancer: The rising incidence of cancers such as multiple myeloma and breast cancer is expected to drive the demand for Aredia.
• Expanding Indications: Potential approvals for new indications, such as other malignancies, could further expand Aredia's market.
• Advancements in Healthcare: Improvements in healthcare infrastructure and increased access to cancer treatments in developing countries are likely to boost the market.

Challenges

• Competition from New Therapies: The emergence of new therapies and drugs could pose a challenge to Aredia's market share.
• Side Effects and Safety Concerns: While Aredia has a generally tolerable side effect profile, ongoing monitoring and potential safety concerns could impact its use.
• Regulatory Environment: Changes in regulatory policies or the approval process could affect the drug's market position.

Key Takeaways

• Aredia has demonstrated significant efficacy in reducing skeletal-related events in patients with multiple myeloma and breast cancer.
• The drug is also effective in treating hypercalcemia of malignancy and Paget's disease.
• The market for Aredia is expected to grow driven by the increasing incidence of cancer and potential new indications.
• However, competition from other bisphosphonates and potential safety concerns need to be monitored.

FAQs

What is Aredia used for?

Aredia (pamidronate disodium) is used to treat high levels of calcium in the blood related to cancer (hypercalcemia of malignancy), osteolytic bone metastases of breast cancer, osteolytic lesions of multiple myeloma, and Paget's disease of bone[2].

How is Aredia administered?

Aredia is administered as an intravenous infusion, typically at a dose of 90 mg in 500 mL of 5% dextrose and water given over 2-4 hours every 3-4 weeks[2][3].

What are the common side effects of Aredia?

Common side effects include asymptomatic hypocalcemia, allergic reactions, transient skeletal pain, arthralgia, myalgia, fever, infusion site irritation, and minor eye problems such as conjunctivitis and eye pain[1][2].

Has Aredia shown benefits in clinical trials?

Yes, Aredia has shown significant benefits in clinical trials by reducing skeletal-related events, improving quality of life, and managing hypercalcemia and Paget's disease effectively[1][3][4].

What is the competitive landscape for Aredia?

Aredia competes with other bisphosphonates like Zometa and Fosamax. However, its specific indications and proven efficacy have maintained its market share[2].

What are the future market projections for Aredia?

The market for Aredia is expected to grow due to the increasing incidence of cancer and potential new indications. However, competition and safety concerns need to be monitored[1][3].

Sources

1. Cancer Network: Aredia Recommended for New Indication in Multiple Myeloma
2. RxList: Aredia (Pamidronate Disodium): Side Effects, Uses, Dosage
3. FDA: Aredia - accessdata.fda.gov
4. FDA: Aredia - accessdata.fda.gov (2012)