CLINICAL TRIALS PROFILE FOR ACTONEL

505(b)(2) Clinical Trials for Actonel

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 Actonel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00051636 ↗	Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period	Completed	Novartis Pharmaceuticals	Phase 3	2001-01-01	The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.
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.
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.
NCT00082277 ↗	Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer	Completed	AstraZeneca	Phase 4	2004-04-01	The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.
NCT00089843 ↗	Bone Loss in Women With Anorexia Nervosa	Completed	National Center for Research Resources (NCRR)	Phase 2/Phase 3	2003-06-01	Women with Anorexia Nervosa have been found to have low bone density. The study will determine whether administration of low doses of a natural hormone, testosterone and/or risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in this condition.

Clinical Trial Conditions for Actonel

Condition Name

Condition Name for Actonel
Intervention	Trials
Osteoporosis	12
Osteoporosis, Postmenopausal	5
Bone Loss	3
Breast Cancer	3

Condition MeSH

Condition MeSH for Actonel
Intervention	Trials
Osteoporosis	19
Osteoporosis, Postmenopausal	7
Bone Diseases, Metabolic	4
Fractures, Bone	3

Clinical Trial Locations for Actonel

Trials by Country

Trials by Country for Actonel
Location	Trials
United States	72
Canada	13
Australia	5
Spain	4
United Kingdom	4

Trials by US State

Trials by US State for Actonel
Location	Trials
North Carolina	5
New York	4
Massachusetts	4
Florida	4
Pennsylvania	4

Clinical Trial Progress for Actonel

Clinical Trial Phase

Clinical Trial Phase for Actonel
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	12
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Actonel
Clinical Trial Phase	Trials
Completed	27
Unknown status	3
Recruiting	2

Clinical Trial Sponsors for Actonel

Sponsor Name

Sponsor Name for Actonel
Sponsor	Trials
Sanofi	10
Procter and Gamble	9
University of Pittsburgh	3

Sponsor Type

Sponsor Type for Actonel
Sponsor	Trials
Other	32
Industry	27
NIH	5

Actonel (Risedronate Sodium): Clinical Trials, Market Analysis, and Projections

Introduction to Actonel

Actonel, also known as risedronate sodium, is a bisphosphonate drug widely used for the treatment of osteoporosis in postmenopausal women and men, as well as for Paget's disease of bone. Here, we will delve into the current clinical trials, market analysis, and future projections for this medication.

Clinical Trials Update

Ongoing and Recent Trials

One significant ongoing clinical trial is the "Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women" (NCT05630768). This Phase 4 trial, sponsored by Dong-A ST Co., Ltd., aims to evaluate the effect of 1 year of risedronate treatment on preventing bone loss after denosumab discontinuation in postmenopausal women who have been treated with denosumab for a year. The trial includes 155 participants and is expected to be completed by February 2025[1].

Historical Trials and Efficacy

Actonel has been extensively studied in numerous clinical trials. In Phase III trials, it was tested in over 5,000 women to evaluate its efficacy in preventing fractures and improving bone mineral density (BMD) in postmenopausal women. These trials, conducted in Europe, Australia, and North America, demonstrated that Actonel significantly reduced fracture incidents and improved BMD in the lumbar spine and other areas[3].

Additionally, Actonel's efficacy in men was tested in a two-year placebo-controlled study involving 284 patients, showing its effectiveness in improving BMD in male patients with osteoporosis. Other studies have also explored the combination of Actonel with conjugated estrogen to enhance BMD[3].

Market Analysis

Current Market Status

Actonel is one of the leading drugs in the osteoporosis market, although its sales have been impacted by the loss of exclusivity and the introduction of generic versions. In the US, for example, Actonel sales declined by 47% in the first quarter of 2012 compared to the same period in the previous year, largely due to the approval of a generic version by the FDA in 2007[3].

Market Segmentation and Projections

The global Actonel market is segmented by type (5 mg, 35 mg, 75 mg, 150 mg), application (osteoporosis, Paget's disease of bone, others), and region (US & Canada, Europe, China, Japan, etc.). The market is projected to grow from 2024 to 2030, with varying Compound Annual Growth Rates (CAGR) across different regions. For instance, the US and Canada market is expected to increase significantly during the forecast period, as are the markets in China and Europe[2].

Key Players and Competitive Landscape

The market for Actonel involves several key players, including Apotex, Warner Chilcott, Teva Pharmaceutical Industries, Mylan, and others. The competitive landscape is influenced by the presence of generic versions and new formulations. For example, the launch of Atelvia, a once-a-month version of Actonel, has helped offset some of the sales decline[2][3].

Market Projections

Global Market Growth

The global Actonel market is anticipated to grow steadily from 2024 to 2030. The report highlights that the market will see significant growth in various regions, driven by increasing awareness and treatment of osteoporosis. The US and Canada, Europe, and China are expected to be key markets, with the latter showing substantial growth due to an aging population and increased healthcare spending[2].

Regional Insights

• US & Canada: The market in these regions is expected to grow, driven by the need for effective osteoporosis treatments and the introduction of new formulations.
• Europe: Despite some decline due to generic competition, the European market remains significant, with ongoing demand for bisphosphonates like Actonel.
• China: This market is projected to see substantial growth, driven by an aging population and increasing healthcare expenditure[2].

Challenges and Future Directions

Safety Concerns and New Formulations

Prolonged use of bisphosphonates like Actonel has raised concerns about atypical fractures, which could impact future sales. However, new formulations and dosing regimens, such as the once-a-month version Atelvia, are helping to mitigate these concerns and maintain market share[3].

Emerging Treatments

Research into new treatments, such as the use of mesenchymal stem cells to regenerate bone tissue, could potentially alter the market landscape. For example, the development of LLP2A-Alendronate, which aims to augment the homing of endogenous mesenchymal stem cells to the bone surface, is an area of ongoing research and could offer future alternatives or complementary treatments to Actonel[4].

Key Takeaways

• Clinical Trials: Actonel is currently being evaluated in a Phase 4 trial to assess its efficacy after denosumab discontinuation.
• Market Analysis: The global Actonel market is segmented by type, application, and region, with significant growth projected in the US, Canada, Europe, and China.
• Competitive Landscape: The market is influenced by key players and the presence of generic versions, with new formulations helping to maintain market share.
• Future Directions: Emerging treatments and safety concerns will continue to shape the market for Actonel.

FAQs

Q: What is the current status of the clinical trial NCT05630768 for Actonel?

A: The trial is active and recruiting, with an estimated completion date of February 2025[1].

Q: How has the introduction of generic versions affected Actonel sales?

A: The introduction of generic versions has significantly impacted Actonel sales, with a 47% decline in the US market in 2012 compared to the previous year[3].

Q: What are the key regions for the Actonel market growth?

A: The key regions include the US, Canada, Europe, and China, with substantial growth projected in these areas[2].

Q: What are the potential future treatments that could impact the Actonel market?

A: Emerging treatments such as LLP2A-Alendronate, which aims to regenerate bone tissue using mesenchymal stem cells, could offer alternative or complementary treatments to Actonel[4].

Q: What is the significance of the new formulation Atelvia in the Actonel market?

A: Atelvia, a once-a-month version of Actonel, has helped offset some of the sales decline due to generic competition and safety concerns[3].

Sources

1. CenterWatch, "Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women" - Clinical Trial.
2. Win Market Research, "Global Actonel (Risedronic Acid) Market Insights, Forecast to 2030".
3. Clinical Trials Arena, "Actonel (Risedronate Sodium) - Treatment for Osteoporosis".
4. CIRM, "Increasing the endogenous mesenchymal stem cells to the bone surface to treat osteoporosis".