CLINICAL TRIALS PROFILE FOR ALENDRONATE SODIUM

All Clinical Trials for ALENDRONATE SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004488 ↗	Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease	Completed	Children's Hospital Medical Center, Cincinnati	Phase 2	1998-10-01	OBJECTIVES: I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	Merck Sharp & Dohme Corp.	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	Columbia University	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.

Clinical Trial Conditions for ALENDRONATE SODIUM

Condition Name

Condition Name for ALENDRONATE SODIUM
Intervention	Trials
Osteoporosis	16
Postmenopausal Osteoporosis	5
Healthy	4
Osteopenia	4

Condition MeSH

Condition MeSH for ALENDRONATE SODIUM
Intervention	Trials
Osteoporosis	26
Osteoporosis, Postmenopausal	8
Bone Diseases, Metabolic	6
Breast Neoplasms	2

Clinical Trial Locations for ALENDRONATE SODIUM

Trials by Country

+

−

Trials by Country for ALENDRONATE SODIUM
Location	Trials
United States	20
Canada	7
Hong Kong	2
Brazil	2
Denmark	2

Trials by US State

+

−

Trials by US State for ALENDRONATE SODIUM
Location	Trials
North Dakota	3
California	3
Colorado	2
Maryland	2
South Carolina	2

Clinical Trial Progress for ALENDRONATE SODIUM

Clinical Trial Phase

Clinical Trial Phase for ALENDRONATE SODIUM
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	13
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ALENDRONATE SODIUM
Clinical Trial Phase	Trials
Completed	29
Not yet recruiting	4
Recruiting	2

Clinical Trial Sponsors for ALENDRONATE SODIUM

Sponsor Name

Sponsor Name for ALENDRONATE SODIUM
Sponsor	Trials
Merck Sharp & Dohme Corp.	12
National Cancer Institute (NCI)	2
Mylan Pharmaceuticals	2

Sponsor Type

Sponsor Type for ALENDRONATE SODIUM
Sponsor	Trials
Other	29
Industry	23
NIH	5

Alendronate Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Alendronate sodium, a bisphosphonate, is widely used in the treatment of osteoporosis and other bone-related disorders. This article provides an update on the clinical trials, market analysis, and future projections for this drug.

Clinical Trials: Efficacy and Safety

Bone Density and Fracture Risk

A significant clinical trial published in JAMA highlighted the effects of alendronate on bone density and fracture risk. The study involved 4432 women randomized to either alendronate or a placebo. The results showed that alendronate increased bone mineral density (BMD) at all measured sites and reduced the risk of clinical fractures, although the reduction was not statistically significant for all types of fractures. Specifically, alendronate reduced the risk of hip fractures by 14% and clinical fractures by 12.3% compared to the placebo group[1].

Generic vs. Brand Alendronate

A randomized clinical trial comparing generic and brand alendronate found that both formulations produced similar gains in BMD and reductions in bone turnover markers. The study concluded that generic and brand alendronate were equally effective and well-tolerated, with no significant differences in BMD changes at the lumbar spine, total hip, or femoral neck after one year of treatment[3].

Long-Term Use and Discontinuation

Another study examined the effects of continuing or stopping alendronate after 5 years. Women who discontinued alendronate showed a moderate decline in BMD and an increase in biochemical markers of bone turnover, but the mean BMD levels remained above pretreatment levels. The study found no significant difference in the cumulative risk of nonvertebral fractures between those who continued and those who discontinued alendronate, although there was a lower risk of clinically recognized vertebral fractures among those who continued the treatment[4].

Market Analysis

Global Market Size and Growth

The global alendronate sodium market is experiencing significant growth. As of 2023, the market size was valued at several million USD and is anticipated to grow at a compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented by type (above 98% and below 98% purity) and application (primarily osteoporosis and other bone-related conditions)[2][5].

Regional Analysis

The market is analyzed across major regions including North America, Europe, Asia-Pacific, Middle East & Africa, and South America. Each region's market dynamics, trends, drivers, restraints, and opportunities are detailed in comprehensive reports. For instance, the Asia-Pacific region is expected to be a significant growth area due to increasing awareness and treatment of osteoporosis[2].

Competitive Landscape

The competitive landscape of the alendronate sodium market includes key players such as Teva Pharmaceutical Industries, Botai Pharma, Wellona Pharma, Hanjiang Pharmaceutical Group, and others. These companies are focusing on strategies to strengthen their product portfolios and expand their global market presence[2][5].

Market Projections

Forecasted Growth

The global alendronate sodium market is projected to continue its growth trajectory from 2025 to 2031. The osteoporosis segment is expected to expand significantly, driven by increasing prevalence of the condition and improved diagnostic and treatment options[2][5].

Market Segments

The market is expected to be most lucrative in the segments with high purity (above 98%) and in the osteoporosis treatment application. These segments are anticipated to experience significant growth due to their high demand and the ongoing research and development in these areas[2].

Technological and Regulatory Trends

The market will also be influenced by technological trends, such as advancements in manufacturing processes, and regulatory changes. For example, the analysis of the manufacturing process and the requirement for major raw materials will continue to be crucial for market players[2].

Key Takeaways

• Clinical Efficacy: Alendronate sodium is effective in increasing BMD and reducing the risk of certain fractures, with similar efficacy between generic and brand formulations.
• Market Growth: The global alendronate sodium market is expected to grow significantly from 2025 to 2031, driven by the osteoporosis segment.
• Regional Dynamics: The Asia-Pacific region is anticipated to be a key growth area due to increasing awareness and treatment of osteoporosis.
• Competitive Landscape: Major pharmaceutical companies are focusing on strengthening their product portfolios and expanding their market presence.

FAQs

What is the primary use of alendronate sodium?

Alendronate sodium is primarily used in the treatment of osteoporosis and other bone-related disorders to increase bone density and reduce the risk of fractures.

How does alendronate sodium compare between generic and brand formulations?

Both generic and brand alendronate sodium have been found to be equally effective and well-tolerated, with no significant differences in BMD changes and reduction in bone turnover markers[3].

What are the long-term effects of discontinuing alendronate sodium?

Discontinuing alendronate sodium after 5 years results in a moderate decline in BMD and an increase in biochemical markers of bone turnover, but the risk of nonvertebral fractures remains similar to those who continue the treatment[4].

Which regions are expected to drive the growth of the alendronate sodium market?

The Asia-Pacific region is expected to be a significant growth area due to increasing awareness and treatment of osteoporosis[2].

Who are the key players in the alendronate sodium market?

Key players include Teva Pharmaceutical Industries, Botai Pharma, Wellona Pharma, Hanjiang Pharmaceutical Group, and others[2][5].

Sources

1. JAMA Network: Effect of Alendronate on Risk of Fracture in Women With Low Bone Density and Osteopenia.
2. Cognitive Market Research: Alendronate Sodium Market Report 2024 (Global Edition).
3. PLOS ONE: Randomized clinical trial comparing efficacy and safety of brand and generic alendronate.
4. JAMA Network: Effects of Continuing or Stopping Alendronate After 5 Years of Treatment.
5. Valuates Reports: Global Alendronate Sodium Market Research Report.