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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR BONIVA

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Clinical Trials for Boniva

Trial ID Title Status Sponsor Phase 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 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 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 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 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 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 Active, not recruiting Roche Pharma AG Phase 3 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Boniva

Condition Name

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

Condition MeSH for Boniva
Intervention Trials
Osteoporosis 12
Osteoporosis, Postmenopausal 8
Bone Diseases, Metabolic 2
Neoplasms 1
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Clinical Trial Locations for Boniva

Trials by Country

Trials by Country for Boniva
Location Trials
United States 141
Puerto Rico 2
Romania 1
Slovenia 1
India 1
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Trials by US State

Trials by US State for Boniva
Location Trials
California 8
Georgia 7
Pennsylvania 7
New York 6
Florida 6
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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
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Clinical Trial Status

Clinical Trial Status for Boniva
Clinical Trial Phase Trials
Completed 12
Active, not recruiting 1
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Clinical Trial Sponsors for Boniva

Sponsor Name

Sponsor Name for Boniva
Sponsor Trials
Hoffmann-La Roche 9
M.D. Anderson Cancer Center 1
Roche Pharma AG 1
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Sponsor Type

Sponsor Type for Boniva
Sponsor Trials
Industry 12
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Express Scripts
Colorcon
Baxter
Mallinckrodt
Julphar
Queensland Health
Medtronic
Dow

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