Boniva (drug)

Ibandronic acid

Clinical data
AHFS/Drugs.com	International Drug Names
License data	EU EMA: by INN US FDA: ibandronate_sodium
Pregnancy category	US: C (Risk not ruled out)
Routes of administration	Oral, intravenous
ATC code	M05BA06 (WHO)
Legal status
Legal status	In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability	0.6%
Protein binding	90.9 to 99.5% (concentration-dependent)
Metabolism	Nil
Biological half-life	10 to 60 hours
Excretion	Renal
Identifiers
IUPAC name {1-Hydroxy-3-[methyl(pentyl)amino]propane-1,1-diyl}bis(phosphonic acid)
CAS Number	114084-78-5 Y
PubChem CID	60852
IUPHAR/BPS	3059
DrugBank	DB00710 N
ChemSpider	54839 Y
UNII	UMD7G2653W
KEGG	D08056 Y
ChEMBL	CHEMBL997 Y
ECHA InfoCard	100.214.537
Chemical and physical data
Formula	C9H23NO7P2
Molar mass	319.229 g/mol
3D model (JSmol)	Interactive image
SMILES O=P(O)(O)C(O)(CCN(CCCCC)C)P(=O)(O)O
InChI InChI=1S/C9H23NO7P2/c1-3-4-5-7-10(2)8-6-9(11,18(12,13)14)19(15,16)17/h11H,3-8H2,1-2H3,(H2,12,13,14)(H2,15,16,17) Y Key:MPBVHIBUJCELCL-UHFFFAOYSA-N Y
NY (what is this?)

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. It may also be used to treat hypercalcemia (elevated blood calcium levels).

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 or muscle pain. 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.