CLINICAL TRIALS PROFILE FOR BONIVA

All Clinical Trials for BONIVA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00148915 ↗	A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo	Completed	Hoffmann-La Roche	Phase 4	2005-08-01	The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.
NCT00303485 ↗	A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)	Completed	Hoffmann-La Roche	Phase 4	2006-02-01	This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is <100 individuals.
NCT00377234 ↗	A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.	Completed	Hoffmann-La Roche	Phase 4	2006-05-01	This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
NCT00545363 ↗	A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)	Completed	Hoffmann-La Roche	Phase 4	2006-04-01	This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months.
NCT00683163 ↗	PTH & Ibandronate Combination Study (PICS)	Completed	University of California, San Francisco	Phase 2/Phase 3	2008-05-01	This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.
NCT00824993 ↗	Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients	Completed	Roche Pharma AG	Phase 3	2008-12-09	The goal of this clinical research study is to see if ibandronate can help to slow the rate of bone loss that may occur in patients who have received a bone marrow transplant for blood cancer. This study plans to address the following hypotheses: 1. The addition of Ibandronate initiated immediately after the transplantation will prevent bone loss in patients undergoing allogenic bone marrow transplantation (BMT) with underlying hematologic malignancies or hematologic disorders. 2. BMT patients who require prolonged steroid and other immunosuppressive treatment for Graft versus Host Diseases(GVHD) have a higher rate of bone loss, which can be prevented or attenuated by Ibandronate. Specific objectives to test these hypotheses are: 1. Primary Objective: 1. To prospectively compare the bone mineral density changes of lumbar spine, femoral neck and total hip between patients randomly assigned to ibandronate and control group over 12 months post bone marrow transplantation at the University of Texas MD Anderson Cancer Center. 2. Secondary Objectives: 1. To measure and compare the accumulated level of steroid used in both treatment and control groups. 2. To collect and compare the level of serum C-terminal telopeptide (CTX) in both treatment and control groups to monitor the bone turnover rate for the duration of the study. 3. To conduct a cost-effectiveness analysis of participating patients for both outcomes on bone mineral density (measured data) and skeletal-related events (modeled data). 4. To record incidence of bone fractures and the graft rate in both treatment and control groups.
NCT00824993 ↗	Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients	Completed	M.D. Anderson Cancer Center	Phase 3	2008-12-09	The goal of this clinical research study is to see if ibandronate can help to slow the rate of bone loss that may occur in patients who have received a bone marrow transplant for blood cancer. This study plans to address the following hypotheses: 1. The addition of Ibandronate initiated immediately after the transplantation will prevent bone loss in patients undergoing allogenic bone marrow transplantation (BMT) with underlying hematologic malignancies or hematologic disorders. 2. BMT patients who require prolonged steroid and other immunosuppressive treatment for Graft versus Host Diseases(GVHD) have a higher rate of bone loss, which can be prevented or attenuated by Ibandronate. Specific objectives to test these hypotheses are: 1. Primary Objective: 1. To prospectively compare the bone mineral density changes of lumbar spine, femoral neck and total hip between patients randomly assigned to ibandronate and control group over 12 months post bone marrow transplantation at the University of Texas MD Anderson Cancer Center. 2. Secondary Objectives: 1. To measure and compare the accumulated level of steroid used in both treatment and control groups. 2. To collect and compare the level of serum C-terminal telopeptide (CTX) in both treatment and control groups to monitor the bone turnover rate for the duration of the study. 3. To conduct a cost-effectiveness analysis of participating patients for both outcomes on bone mineral density (measured data) and skeletal-related events (modeled data). 4. To record incidence of bone fractures and the graft rate in both treatment and control groups.

Clinical Trial Conditions for BONIVA

Condition Name

Condition Name for BONIVA
Intervention	Trials
Post Menopausal Osteoporosis	4
Postmenopausal Osteoporosis	4
Osteoporosis	3
Hematological Malignancies	1

Condition MeSH

Condition MeSH for BONIVA
Intervention	Trials
Osteoporosis	12
Osteoporosis, Postmenopausal	8
Bone Diseases, Metabolic	2
Neoplasms	1

Clinical Trial Locations for BONIVA

Trials by Country

Trials by Country for BONIVA
Location	Trials
United States	141
Puerto Rico	2
Latvia	1
Russian Federation	1
Germany	1

Trials by US State

Trials by US State for BONIVA
Location	Trials
California	8
Pennsylvania	7
Georgia	7
New York	6
Florida	6

Clinical Trial Progress for BONIVA

Clinical Trial Phase

Clinical Trial Phase for BONIVA
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for BONIVA
Clinical Trial Phase	Trials
Completed	13

Clinical Trial Sponsors for BONIVA

Sponsor Name

Sponsor Name for BONIVA
Sponsor	Trials
Hoffmann-La Roche	9
University of California, San Francisco	1
Roche Pharma AG	1

Sponsor Type

Sponsor Type for BONIVA
Sponsor	Trials
Industry	12
Other	2

BONIVA Market Analysis and Financial Projection

Boniva: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Boniva

Boniva, also known as ibandronate sodium, is a bisphosphonate medication approved by the FDA for the treatment and prevention of postmenopausal osteoporosis. It is available in both oral and intravenous (IV) formulations, offering flexibility in treatment options.

Clinical Trials and Efficacy

Approval and Clinical Trials

Boniva Injection was approved by the FDA in 2006 based on the results of the DIVA study (Dosing IntraVenous Administration), a randomized, double-blind, multinational, non-inferiority trial involving 1,358 women with postmenopausal osteoporosis. This study compared the efficacy of Boniva Injection (3 mg once every three months) with the daily oral formulation of Boniva (2.5 mg)[1].

Key Findings

• The DIVA study showed that Boniva Injection resulted in a statistically superior increase in lumbar spine bone mineral density (BMD) compared to the daily oral tablets, with a 4.5% increase versus 3.5%, respectively (p < 0.001)[1].
• Patients treated with Boniva Injection also had higher BMD increases in the total hip, femoral neck, and trochanter compared to those treated with oral daily Boniva[1].

Safety and Tolerability

The safety and tolerability profiles of Boniva Injection and Boniva Tablets were similar in a one-year study. Common adverse events included arthralgia, back pain, influenza, hypertension, abdominal pain, and nasopharyngitis. Acute phase reaction-like events were reported in some patients, particularly after the first injection, but these were generally mild and resolved within 24-48 hours[1].

Market Analysis

Current Market Size

The osteoporosis market, which includes Boniva, has seen significant growth. As of 2023, the osteoporosis market size was valued at USD 10.2 billion, with projections indicating it will reach USD 14.8 billion by 2034, growing at a CAGR of 3.49% during 2024-2034[2].

Market Drivers

• New Drug Developments: The market is driven by innovative treatment approaches, including biologic therapies such as romosozumab (Evenity) and denosumab (Prolia), which offer improved efficacy and safety profiles[2].
• Diagnostic Advancements: Enhancements in diagnostic technologies, including bone density scanning and biomarkers, are improving early detection and personalized treatment strategies[2].

Regional Analysis

The United States has the largest patient pool for osteoporosis and represents the biggest market for its treatment. This is attributed to advancements in treatment options, increased awareness, and substantial investment in research and development[2].

Market Projections for Boniva

Sales and Market Share

Boniva, as part of the broader osteoporosis market, is expected to benefit from the growing demand for effective osteoporosis treatments. While specific sales projections for Boniva are not detailed, the overall market growth indicates a positive outlook for bisphosphonate medications like Boniva.

Competitive Landscape

Boniva competes with other osteoporosis treatments, including:

• Evenity (Romosozumab): A monoclonal antibody that inhibits sclerostin, promoting bone formation and reducing bone resorption[2].
• Prolia (Denosumab): A monoclonal antibody that targets and inhibits RANK ligand, a key regulator of bone resorption[2].
• Reclast (Zoledronic acid): Another bisphosphonate medication used for osteoporosis treatment[3].

Despite the competition, Boniva's unique dosing regimen, particularly the quarterly IV injection, provides an alternative for patients who struggle with oral bisphosphonate dosing requirements, maintaining its relevance in the market[1].

Key Takeaways

• Clinical Efficacy: Boniva Injection has demonstrated superior BMD increases compared to daily oral Boniva in clinical trials.
• Market Growth: The osteoporosis market is expected to grow significantly, driven by new drug developments and diagnostic advancements.
• Competitive Position: Boniva remains a viable option in the osteoporosis treatment market due to its unique dosing regimen and established efficacy.

FAQs

What is Boniva used for?

Boniva (ibandronate sodium) is used to treat and prevent postmenopausal osteoporosis, helping to strengthen bones and reduce the risk of fractures.

How is Boniva administered?

Boniva is available in both oral and intravenous (IV) formulations. The IV injection is administered once every three months by a healthcare professional.

What are the common side effects of Boniva?

Common side effects include arthralgia, back pain, influenza, hypertension, abdominal pain, and nasopharyngitis. Acute phase reaction-like events can occur after the first injection but are generally mild and temporary.

How does Boniva compare to other osteoporosis treatments?

Boniva offers a unique dosing regimen, particularly the quarterly IV injection, which is beneficial for patients who have difficulty with oral bisphosphonate dosing requirements. It competes with other treatments like Evenity and Prolia but maintains its relevance due to its established efficacy and convenience.

What is the projected market size for the osteoporosis treatment market by 2034?

The osteoporosis market is expected to reach USD 14.8 billion by 2034, growing at a CAGR of 3.49% during 2024-2034.

Sources

1. Roche Approves First IV Treatment For Postmenopausal Osteoporosis - BioSpace
2. Osteoporosis Market Size to Reach USD 14.8 Billion by 2034 - BioSpace
3. Osteoporosis Market: Epidemiology, Industry Trends, Share, Size - Research and Markets
4. Ibandronate (intravenous route) - Mayo Clinic
5. Postmenopausal Osteoporosis Treatment Market Size, Report 2034 - Precedence Research