CLINICAL TRIALS PROFILE FOR RISEDRONATE SODIUM

505(b)(2) Clinical Trials for RISEDRONATE SODIUM

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00632216 ↗	A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis	Completed	Sanofi	Phase 4	2004-05-01	The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week.

All Clinical Trials for RISEDRONATE SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00054418 ↗	Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2003-03-01	RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss. PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.
NCT00054418 ↗	Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2003-03-01	RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss. PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.
NCT00043069 ↗	Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2002-11-01	RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis. PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.
NCT00043069 ↗	Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2002-11-01	RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis. PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.

Clinical Trial Conditions for RISEDRONATE SODIUM

Condition Name

Condition Name for RISEDRONATE SODIUM
Intervention	Trials
Osteoporosis	6
Breast Cancer	4
Osteoporosis, Postmenopausal	4
Prostate Cancer	1

Condition MeSH

Condition MeSH for RISEDRONATE SODIUM
Intervention	Trials
Osteoporosis	11
Osteoporosis, Postmenopausal	4
Breast Neoplasms	4
Fractures, Bone	2

Clinical Trial Locations for RISEDRONATE SODIUM

Trials by Country

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−

Trials by Country for RISEDRONATE SODIUM
Location	Trials
United States	49
Canada	10
Japan	4
United Kingdom	3
France	2

Trials by US State

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−

Trials by US State for RISEDRONATE SODIUM
Location	Trials
Pennsylvania	3
North Carolina	3
Florida	3
Ohio	2
Louisiana	2

Clinical Trial Progress for RISEDRONATE SODIUM

Clinical Trial Phase

Clinical Trial Phase for RISEDRONATE SODIUM
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for RISEDRONATE SODIUM
Clinical Trial Phase	Trials
Completed	15
Withdrawn	1

Clinical Trial Sponsors for RISEDRONATE SODIUM

Sponsor Name

Sponsor Name for RISEDRONATE SODIUM
Sponsor	Trials
Sanofi	5
Procter and Gamble	4
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for RISEDRONATE SODIUM
Sponsor	Trials
Industry	14
Other	8
NIH	3

Risedronate Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Risedronate sodium, a bisphosphonate drug, is widely used in the treatment and prevention of osteoporosis and other bone-related disorders. This article delves into the recent clinical trials, market analysis, and future projections for risedronate sodium.

Clinical Trials Update

Efficacy and Safety in Postmenopausal Osteoporosis

A significant Phase III clinical trial presented at the American Society for Bone and Mineral Research (ASBMR) evaluated the efficacy and safety of risedronate 150 mg once monthly compared to the daily 5 mg dose. The study found that both dosing regimens resulted in similar increases in bone mineral density (BMD) at the lumbar spine, total hip, femoral neck, and femoral trochanter over 12 months. The tolerability and safety profiles were also similar between the two groups[1].

Efficacy in Male Osteoporosis

Another Phase III trial, presented at the International Osteoporosis Foundation (IOF) World Congress on Osteoporosis, demonstrated the efficacy of risedronate sodium tablets in treating male osteoporosis. Patients treated with risedronate 35 mg once a week showed a statistically significant 4.5% increase in lumbar spine BMD compared to the placebo group over two years. The trial also reported significant reductions in bone turnover markers and a well-tolerated safety profile[3].

Reduction in Fracture Risk

A comprehensive trial published in JAMA highlighted the effectiveness of daily risedronate therapy in reducing the risk of vertebral and nonvertebral fractures in postmenopausal women. The study showed a 41% reduction in new vertebral fractures and a 39% reduction in nonvertebral fractures over three years, along with significant increases in BMD at various sites[4].

Market Analysis

Market Size and Growth

The risedronate sodium API market has experienced rapid growth in recent years and is projected to continue this trend from 2023 to 2031. The market is segmented by type (purity levels of ≥99% and ≥99.5%), application (tablets and capsules), and geographical regions. The positive market dynamics, driven by increasing demand for bone health medications, are expected to sustain robust growth rates during the forecast period[2].

Market Drivers

Several factors are driving the growth of the risedronate sodium market:

• Growing Aging Population: The increasing number of elderly individuals contributes significantly to the demand for bone health-related medications.
• Rising Awareness: Greater awareness about bone health and osteoporosis prevention is promoting the use of calcium regulators like risedronate sodium.
• Innovations in Delivery Systems: Advances in oral medication delivery systems are improving patient compliance and treatment outcomes[5].

Market Restraints

Despite the growth, the market faces several challenges:

• High Development Costs: The cost of drug development and regulatory hurdles in clinical trials pose significant barriers.
• Supply Chain Challenges: Logistical issues faced by suppliers can impact market stability.
• Alternative Treatments: The emergence of alternative bisphosphonate options and biologics could limit market growth[5].

Market Projections

Future Growth

The risedronate sodium market is expected to see substantial growth from 2023 to 2031, driven by the increasing incidence of osteoporosis and other bone-related illnesses. The market is anticipated to expand in emerging markets where osteoporosis treatments are becoming more prevalent[2].

Opportunities

Several opportunities are identified for future growth:

• Enhanced Marketing Strategies: Personalized patient engagement and support programs can enhance market share.
• Digital Health Tools: Leveraging digital health tools to educate patients and monitor medication adherence can improve treatment outcomes.
• Expanded Indications: Conducting clinical trials to expand the indications for risedronate sodium beyond osteoporosis treatment could open new market avenues[5].

Challenges

The market will need to address several challenges:

• Regulatory Reforms: Navigating regulatory reforms affecting distribution and approval processes will be crucial.
• Market Competition: Addressing competition from alternative bisphosphonate options and managing market pricing will be essential for maintaining market share[5].

Key Takeaways

• Risedronate sodium has demonstrated efficacy and safety in various clinical trials for treating osteoporosis in both postmenopausal women and men.
• The market for risedronate sodium is growing rapidly, driven by an aging population and increasing awareness of bone health.
• Innovations in delivery systems and personalized medicine approaches are expected to drive future growth.
• The market faces challenges such as high development costs, supply chain issues, and competition from alternative treatments.

FAQs

What is the primary use of risedronate sodium?

Risedronate sodium is primarily used to treat and prevent osteoporosis and other bone-related disorders by preventing bone loss and increasing bone mineral density.

How effective is risedronate sodium in reducing fracture risk?

Clinical trials have shown that risedronate sodium can reduce the risk of vertebral and nonvertebral fractures by up to 41% and 39%, respectively, over three years.

What are the common adverse events associated with risedronate sodium?

Common adverse events include upper abdominal pain, influenza, constipation, back pain, arthralgia, and nasopharyngitis.

What are the market drivers for risedronate sodium?

Market drivers include the growing aging population, rising awareness about bone health, and innovations in oral medication delivery systems.

What challenges does the risedronate sodium market face?

The market faces challenges such as high drug development costs, supply chain issues, and competition from alternative treatments like biologics.

Sources

1. New Phase III Data Presented for Once Monthly Dosing Regimen of Risedronate to Treat Postmenopausal Osteoporosis. Procter & Gamble News Releases.
2. Risedronate Sodium API Market Size, Scope And Forecast Report. Market Research Intellect.
3. New Phase III data reports on the safety and efficacy of Risedronate. Sanofi US Press Releases.
4. Effects of Risedronate Treatment on Vertebral and Nonvertebral Fractures in Women with Postmenopausal Osteoporosis. JAMA.
5. Risedronate Sodium Tablets Market Size & Share 2025-2030. 360 Research Reports.