Active Ingredient History
Ibandronic acid (INN) or ibandronate sodium (USAN) is a potent bisphosphonate drug developed by Hoffman La Roche and used in the prevention and treatment of osteoporosis and metastasis-associated skeletal fractures in people with cancer. Ibandronate is indicated for the treatment and prevention of osteoporosis in post-menopausal women. In May 2003, the U.S. Food and Drug Administration (FDA) approved Ibandronate as a daily treatment for post-menopausal osteoporosis. The basis for this approval was a three-year, randomized, double-blind, placebo-controlled trial women with post-menopausal osteoporosis. Every participant also received daily oral doses of calcium and 400IUs [international units] of vitamin D. At the study's conclusion, both doses significantly reduced the occurrence risk of new vertebral fractures by 50–52 percent when compared to the effects of the placebo drug. Ibandronate is efficacious for the prevention of metastasis-related bone fractures in multiple myeloma, breast cancer, and certain other cancers. In 2008, the U.S Food and Drug Administration (FDA) issued a communication warning of the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain.[4] A study conducted by the American Society of Bone and Mineral Research concluded that long-term use of bisphosphonates, including Boniva, may increase the risk of a rare but serious fracture of the femur. Ibandronic acid is marketed under the trade names Boniva in the USA, Bondronat in Europe, Bonviva in Asia, Ibandrix in Ecuador and Bondrova in Bangladesh. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Arthritis, Rheumatoid (Phase 4)
Bone Diseases, Metabolic (Phase 4)
Bone Marrow Diseases (Phase 3)
Bone Neoplasms (Phase 3)
Breast Neoplasms (Phase 3)
Fibrosis (Phase 4)
Healthy Volunteers (Phase 1)
Hematologic Neoplasms (Phase 3)
Hip Injuries (Phase 3)
HIV Infections (Phase 4)
Kidney Transplantation (Phase 2/Phase 3)
Knee Injuries (Phase 3)
Lung Neoplasms (Phase 4)
Lupus Erythematosus, Systemic (Phase 4)
Menopause (Phase 4)
Multiple Myeloma (Phase 3)
Neoplasm Metastasis (Phase 3)
Neoplasms (Phase 3)
Osteoporosis (Phase 4)
Osteoporosis, Postmenopausal (Phase 4)
Pain (Phase 4)
Prostatic Neoplasms (Phase 3)
| Trial | Phase | Start Date | Organizations | Indications |
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