CLINICAL TRIALS PROFILE FOR IBANDRONATE SODIUM

All Clinical Trials for Ibandronate Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00082927 ↗	Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain	Completed	Cancer Research UK	Phase 3	2003-04-01	RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether ibandronate is more effective than standard treatment with radiation therapy in treating metastatic bone pain. PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.
NCT00127205 ↗	S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.	Completed	Cancer and Leukemia Group B	Phase 3	2005-07-01	RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
NCT00127205 ↗	S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.	Completed	Eastern Cooperative Oncology Group	Phase 3	2005-07-01	RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
NCT00127205 ↗	S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.	Completed	National Cancer Institute (NCI)	Phase 3	2005-07-01	RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
NCT00127205 ↗	S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.	Completed	NCIC Clinical Trials Group	Phase 3	2005-07-01	RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
NCT00127205 ↗	S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.	Completed	North Central Cancer Treatment Group	Phase 3	2005-07-01	RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
NCT00127205 ↗	S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.	Completed	NSABP Foundation Inc	Phase 3	2005-07-01	RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.

Clinical Trial Conditions for Ibandronate Sodium

Condition Name

Condition Name for Ibandronate Sodium
Intervention	Trials
Breast Cancer	4
Metastatic Cancer	3
Pain	2
Hypercalcemia of Malignancy	2

Condition MeSH

Condition MeSH for Ibandronate Sodium
Intervention	Trials
Breast Neoplasms	4
Neoplasm Metastasis	3
Osteoporosis	2
Paraneoplastic Syndromes	2

Clinical Trial Locations for Ibandronate Sodium

Trials by Country

Trials by Country for Ibandronate Sodium
Location	Trials
United States	23
United Kingdom	7
India	1

Trials by US State

Trials by US State for Ibandronate Sodium
Location	Trials
Pennsylvania	2
New York	2
New Mexico	2
Michigan	2
Maryland	2

Clinical Trial Progress for Ibandronate Sodium

Clinical Trial Phase

Clinical Trial Phase for Ibandronate Sodium
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Ibandronate Sodium
Clinical Trial Phase	Trials
Completed	5
Withdrawn	2
Unknown status	1

Clinical Trial Sponsors for Ibandronate Sodium

Sponsor Name

Sponsor Name for Ibandronate Sodium
Sponsor	Trials
Southwest Oncology Group	3
National Cancer Institute (NCI)	3
North Central Cancer Treatment Group	1

Sponsor Type

Sponsor Type for Ibandronate Sodium
Sponsor	Trials
Other	11
Industry	3
NIH	3

Ibandronate Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Ibandronate Sodium

Ibandronate sodium, a potent nitrogen-containing bisphosphonate, is widely used in the treatment and prevention of osteoporosis in postmenopausal women. It works by inhibiting bone resorption, thereby increasing bone mineral density and reducing the incidence of vertebral fractures.

Clinical Trials and Efficacy

Safety and Pharmacodynamics

A significant clinical trial, the Monthly Oral Pilot Study, investigated the safety, pharmacodynamics, and pharmacokinetics of once-monthly oral ibandronate. This randomized, 3-month, double-blind, placebo-controlled study involved postmenopausal women aged 55-80 years. The results showed that once-monthly oral ibandronate was well tolerated, with a safety profile similar to that of the placebo, particularly in terms of upper gastrointestinal safety[1].

The study also demonstrated the efficacy of ibandronate in reducing bone turnover. Substantial reductions in serum and urinary C-telopeptide (CTX) levels were observed, indicating a significant decrease in bone resorption. Specifically, the 150 mg and 100 mg doses resulted in reductions of 56.7% and 40.7% in serum CTX, and 54.1% and 34.6% in urinary CTX, respectively, compared to the placebo group[1].

FDA Approval and Indications

Ibandronate sodium, marketed under the brand name Boniva, was approved by the FDA for the treatment and prevention of osteoporosis in postmenopausal women. The approval includes a monthly oral regimen of 150 mg, which has been shown to increase bone mineral density and reduce the incidence of vertebral fractures[4].

Market Analysis

Market Size and Growth

The global ibandronate sodium market is experiencing rapid growth, driven by increasing demand for effective treatments for osteoporosis and hypercalcemia. The market size is projected to expand significantly from 2023 to 2031, with a compound annual growth rate (CAGR) that indicates robust growth rates in the foreseeable future[2][5].

Segmentation and Regional Analysis

The ibandronate sodium market is segmented based on type (e.g., 4ml:2mg, 2ml:2mg, 1:1mg) and application (osteoporosis and hypercalcemia). Geographically, the market is divided into major regions including North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region is analyzed for its revenue share, current trends, and future market opportunities[2][3][5].

Key Players and Competitor Analysis

The market is competitive, with key players such as Roche, Qilu Pharmaceutical Co. Ltd., Hebei Renhe Yikang Pharmaceutical Co. Ltd, and Chengdu Yuandong Biopharmaceutical Co. Ltd. These companies are driving innovation and expansion in the market through various strategies, including product development and geographical expansion[3].

Market Dynamics and Trends

Drivers and Opportunities

The growth of the ibandronate sodium market is driven by several factors, including the increasing prevalence of osteoporosis, especially among postmenopausal women, and the need for effective and convenient treatment options. The once-monthly oral dosing regimen of ibandronate sodium addresses adherence issues associated with daily and weekly oral bisphosphonates, making it a preferred choice for many patients[1][2].

Restraints and Challenges

Despite the positive outlook, the market faces certain restraints, such as potential side effects associated with bisphosphonates, including gastrointestinal disorders, hypocalcemia, severe bone, joint, and muscle pain, and the risk of osteonecrosis of the jaw. These adverse reactions can impact patient compliance and overall market growth[4].

Projections and Future Outlook

Forecasted Growth

The global ibandronate sodium market is expected to continue its robust growth from 2023 to 2031. The market size is forecasted to increase significantly, driven by the expanding patient population and the increasing adoption of once-monthly oral ibandronate regimens. Regional analyses indicate that Asia-Pacific and Latin America will be key growth regions due to their large and aging populations[2][3][5].

Technological and Regulatory Trends

Advancements in pharmaceutical technology and changes in regulatory environments are also expected to influence the market. For instance, ongoing research into new formulations and delivery methods could further enhance the efficacy and safety profile of ibandronate sodium. Additionally, regulatory approvals and guidelines will continue to shape the market landscape[3][5].

Key Takeaways

• Clinical Efficacy: Ibandronate sodium has been proven to be effective in reducing bone turnover and increasing bone mineral density, making it a valuable treatment for postmenopausal osteoporosis.
• Market Growth: The global ibandronate sodium market is projected to experience significant growth from 2023 to 2031, driven by increasing demand and the convenience of once-monthly oral dosing.
• Regional Analysis: The market is segmented geographically, with Asia-Pacific and Latin America expected to be key growth regions.
• Competitive Landscape: The market is competitive, with several key players driving innovation and expansion.
• Challenges: Despite the positive outlook, the market faces challenges related to potential side effects and regulatory environments.

FAQs

Q: What is the primary indication for ibandronate sodium?

A: Ibandronate sodium is primarily indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Q: What is the dosing regimen for ibandronate sodium?

A: Ibandronate sodium is available in a once-monthly oral regimen of 150 mg, which has been shown to be effective and well-tolerated.

Q: What are the common side effects of ibandronate sodium?

A: Common side effects include back pain, dyspepsia, pain in extremity, diarrhea, headache, and myalgia. Severe side effects can include gastrointestinal disorders, hypocalcemia, and osteonecrosis of the jaw[4].

Q: Which regions are expected to drive the growth of the ibandronate sodium market?

A: Asia-Pacific and Latin America are expected to be key growth regions due to their large and aging populations.

Q: Who are the key players in the ibandronate sodium market?

A: Key players include Roche, Qilu Pharmaceutical Co. Ltd., Hebei Renhe Yikang Pharmaceutical Co. Ltd, and Chengdu Yuandong Biopharmaceutical Co. Ltd.

Sources

1. Monthly Oral Ibandronate Is Well Tolerated and Efficacious in Postmenopausal Osteoporosis - Journal of Clinical Endocrinology and Metabolism[1].
2. Global Ibandronate Sodium Market Size, Scope And Forecast Report - Market Research Intellect[2].
3. Ibandronate Sodium Injection Market Report 2024 (Global Edition) - Cognitive Market Research[3].
4. Ibandronate Sodium - FDA Approval Package - FDA[4].
5. Global Ibandronate Sodium Market Report 2024 Edition - Cognitive Market Research[5].