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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR ATELVIA


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All Clinical Trials for ATELVIA

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04922333 ↗ Bisphosphonate Use to Mitigate Bone Loss Not yet recruiting Wake Forest University Health Sciences Phase 3 2022-07-01 The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy. Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).
NCT03861091 ↗ Prophylactic Riserodrenate for Patients With Peripheral Lung Tumors Treated With SBRT Recruiting National Cancer Institute (NCI) Phase 2 2019-07-12 This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation. Patients will be given either a single dose of 150 mg risedronate or placebo at the time of their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3 weeks following this mapping scan, as each treatment plan requires detailed physics calculations and quality assurance checks. All CT imaging referenced below is performed as a routine standard of care surveillance and is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this research protocol would be performed every 3 months regardless of inclusion on this trial.
NCT03861091 ↗ Prophylactic Riserodrenate for Patients With Peripheral Lung Tumors Treated With SBRT Recruiting Wake Forest University Health Sciences Phase 2 2019-07-12 This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation. Patients will be given either a single dose of 150 mg risedronate or placebo at the time of their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3 weeks following this mapping scan, as each treatment plan requires detailed physics calculations and quality assurance checks. All CT imaging referenced below is performed as a routine standard of care surveillance and is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this research protocol would be performed every 3 months regardless of inclusion on this trial.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for ATELVIA

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1Bone LossLung NeoplasmLung Tumor[disabled in preview]
Condition Name for ATELVIA
Intervention Trials
Bone Loss 1
Lung Neoplasm 1
Lung Tumor 1
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Condition MeSH

110-0.100.10.20.30.40.50.60.70.80.911.1Bone Diseases, MetabolicLung Neoplasms[disabled in preview]
Condition MeSH for ATELVIA
Intervention Trials
Bone Diseases, Metabolic 1
Lung Neoplasms 1
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Clinical Trial Locations for ATELVIA

Trials by Country

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Trials by Country for ATELVIA
Location Trials
United States 2
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Trials by US State

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Trials by US State for ATELVIA
Location Trials
North Carolina 2
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Clinical Trial Progress for ATELVIA

Clinical Trial Phase

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for ATELVIA
Clinical Trial Phase Trials
Phase 3 1
Phase 2 1
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Clinical Trial Status

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1Not yet recruitingRecruiting[disabled in preview]
Clinical Trial Status for ATELVIA
Clinical Trial Phase Trials
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for ATELVIA

Sponsor Name

trials000111112222Wake Forest University Health SciencesNational Cancer Institute (NCI)[disabled in preview]
Sponsor Name for ATELVIA
Sponsor Trials
Wake Forest University Health Sciences 2
National Cancer Institute (NCI) 1
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Sponsor Type

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2OtherNIH[disabled in preview]
Sponsor Type for ATELVIA
Sponsor Trials
Other 2
NIH 1
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Clinical Trials, Market Analysis, and Projections for Atelvia (Risedronate Sodium)

Introduction to Atelvia

Atelvia, known generically as risedronate sodium, is a bisphosphonate medication specifically formulated in a delayed-release tablet form. It is indicated for the treatment of postmenopausal osteoporosis, a condition characterized by low bone mass and structural deterioration of bone tissue, leading to increased susceptibility to fractures[2][4].

Clinical Trials Overview

Phase and Study Design

The clinical efficacy and safety of Atelvia were evaluated in a 1-year, double-blind, multicenter study. This study compared Atelvia 35 mg once-a-week to risedronate sodium immediate-release 5 mg daily in postmenopausal women aged 50 years and older. The study included patients with pre-existing gastrointestinal diseases and those using concomitant medications such as non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H2 antagonists[3][4].

Key Findings

  • Efficacy: The study demonstrated that Atelvia 35 mg once-a-week was as effective as risedronate sodium immediate-release 5 mg daily in treating postmenopausal osteoporosis. Both regimens showed significant improvements in bone density and reduction in the risk of fractures[3][4].
  • Safety and Tolerability: The overall safety and tolerability profiles of Atelvia and the immediate-release formulation were similar. Common adverse reactions included gastrointestinal disorders such as diarrhea, abdominal pain, constipation, and musculoskeletal adverse reactions like arthralgia and back pain. The incidence of serious adverse reactions and study discontinuations due to adverse reactions were comparable between the two groups[3][4].

Administration and Patient Compliance

Atelvia is administered once a week, either at least 30 minutes before breakfast or immediately following breakfast. This dosing regimen was found to be more convenient and had a lower incidence of abdominal pain when taken after breakfast compared to fasting conditions[3][4].

Market Analysis

Current Market Status

Atelvia was approved by the FDA in October 2010 for the treatment of postmenopausal osteoporosis. It is part of the bisphosphonate class, which is a well-established market segment for osteoporosis treatment. The delayed-release formulation of Atelvia offers a unique advantage in terms of patient compliance and convenience compared to immediate-release formulations[2][4].

Market Growth and Projections

The market for risedronate sodium, including Atelvia, has experienced substantial growth and is projected to continue this trend from 2023 to 2031. This growth is driven by the increasing prevalence of osteoporosis, particularly among postmenopausal women, and the preference for convenient and well-tolerated treatment options[5].

Competitive Landscape

Atelvia competes with other bisphosphonates, including its predecessor Actonel, which is available in various strengths and formulations. However, the delayed-release formulation of Atelvia provides a distinct advantage in terms of patient compliance and reduced gastrointestinal side effects when taken after breakfast[3][4].

Market Projections

Demand and Usage

The demand for Atelvia is expected to rise due to several factors:

  • Increasing Prevalence of Osteoporosis: The National Osteoporosis Foundation estimates that 44 million Americans, or 55% of people aged 50 years and older, either have or are at high risk for osteoporosis. This demographic trend is expected to drive the demand for effective osteoporosis treatments[2].
  • Patient Preference: The once-a-week dosing regimen of Atelvia enhances patient compliance, which is a critical factor in the long-term management of osteoporosis.
  • Clinical Efficacy and Safety: The robust clinical data supporting the efficacy and safety of Atelvia will continue to influence prescribing decisions in favor of this medication.

Economic Factors

The economic viability of Atelvia is supported by its approval and inclusion in various healthcare plans. The cost-effectiveness of a once-a-week regimen compared to daily dosing can also contribute to its market appeal. However, the generic competition from other risedronate sodium products may impact the pricing and market share of Atelvia[5].

Key Takeaways

  • Clinical Efficacy: Atelvia has demonstrated efficacy comparable to immediate-release risedronate sodium in treating postmenopausal osteoporosis.
  • Safety and Tolerability: The medication has a favorable safety profile, especially when administered after breakfast.
  • Market Growth: The market for risedronate sodium is projected to grow significantly from 2023 to 2031.
  • Competitive Advantage: The delayed-release formulation of Atelvia offers enhanced patient compliance and convenience.
  • Economic Factors: The cost-effectiveness and inclusion in healthcare plans support the economic viability of Atelvia.

FAQs

What is Atelvia used for?

Atelvia is used for the treatment of postmenopausal osteoporosis, a condition characterized by low bone mass and increased susceptibility to fractures.

How is Atelvia administered?

Atelvia is administered as a 35 mg delayed-release tablet once a week, either at least 30 minutes before breakfast or immediately following breakfast.

What are the common side effects of Atelvia?

Common side effects include gastrointestinal disorders such as diarrhea, abdominal pain, and constipation, as well as musculoskeletal adverse reactions like arthralgia and back pain.

How does Atelvia compare to other bisphosphonates?

Atelvia offers a unique advantage with its delayed-release formulation, which enhances patient compliance and reduces gastrointestinal side effects when taken after breakfast.

What is the market outlook for Atelvia?

The market for Atelvia is expected to grow due to the increasing prevalence of osteoporosis, patient preference for convenient dosing regimens, and the medication's clinical efficacy and safety profile.

Are there generic versions of Atelvia available?

Yes, generic versions of risedronate sodium are available, which may impact the market share and pricing of Atelvia[5].

Sources

  1. Managed Healthcare Executive: Risedronate sodium delayed-release tablets (Atelvia)[2].
  2. RxAbbVie: ATELVIA® (risedronate sodium) delayed-release tablets - Prescribing Information[4].
  3. DrugPatentWatch: Generic RISEDRONATE SODIUM INN entry, drug patent expiration[5].

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