title: Oral daily ibandronate prevents bone loss in early postmenopausal women without osteoporosis.
abstract: Oral daily ibandronate was investigated for the prevention of bone loss in postmenopausal women without osteoporosis (n = 653). BMD at the lumbar spine and hip were significantly increased (3.1% and 1.8%, respectively; p < or = 0.0001 versus placebo) with 2.5 mg ibandronate after 24 months. Oral ibandronate is a promising option for the prevention of postmenopausal bone loss.
  
  
  BACKGROUND
  Further strategies to manage patients most at risk from developing postmenopausal osteoporosis are required. The objectives of this multicenter, double-blind, randomized, placebo-controlled study were to examine the efficacy, tolerability, and optimal dose of oral daily ibandronate in the prevention of bone loss in postmenopausal women.
  
  
  METHODS
  In total, 653 women (mean bone mineral density [BMD] T-score > -2.5 at the lumbar spine), who had been postmenopausal for at least 1 year, were allocated to one of four strata based on time since menopause and baseline lumbar spine BMD. Women were randomized to receive calcium (500 mg daily) plus either placebo (n = 162) or ibandronate 0.5 mg (n = 162), 1 mg (n = 166), or 2.5 mg (n = 163) as once-daily oral treatment for 2 years. The primary endpoint was the mean percent change in lumbar spine BMD with ibandronate versus placebo.
  
  
  CONCLUSIONS
  After 2 years, oral daily ibandronate produced a dose-related and sustained maintenance or increase in BMD at the lumbar spine and hip (total hip, femoral neck, trochanter), together with a dose-related reduction in the rate of bone turnover. The greatest nominal increases in spinal and hip BMD were observed with the 2.5-mg dose, which produced statistically significant BMD gains compared with placebo at 6 months and all subsequent time-points at the spine and hip (3.1% and 1.8% increase in lumbar spine and total hip BMD, respectively, versus placebo; p < or = 0.0001 after 24 months). Oral daily ibandronate was well tolerated with an incidence of upper gastrointestinal adverse events similar to placebo. No safety concerns were identified. In summary, oral daily ibandronate 2.5 mg decreases bone turnover, preserves or increases BMD in the spine and proximal femur, and is well tolerated. Oral ibandronate provides a promising option for the prevention of bone loss in postmenopausal women.
authors.affiliation: Oregon Osteoporosis Center, Portland, Oregon 97213, USA. mmcclung@orost.com
authors.forename: Michael R
authors.initials: MR
authors.lastname: McClung
authors.forename: Richard D
authors.initials: RD
authors.lastname: Wasnich
authors.forename: Robert
authors.initials: R
authors.lastname: Recker
authors.forename: Jane A
authors.initials: JA
authors.lastname: Cauley
authors.forename: Charles H
authors.initials: CH
authors.lastname: Chesnut
authors.forename: Kristine E
authors.initials: KE
authors.lastname: Ensrud
authors.forename: Alexander
authors.initials: A
authors.lastname: Burdeska
authors.forename: Tracy
authors.initials: T
authors.lastname: Mills
mesh_terms: D000368:Aged; D015519:Bone Density / Q000187:drug effects; D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism; D002170:Canada; D003094:Collagen / Q000097:blood / Q000652:urine; D024042:Collagen Type I; D003627:Data Interpretation, Statistical; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005269:Femur / Q000737:chemistry; D005272:Femur Neck / Q000737:chemistry; D006801:Humans; D000077557:Ibandronic Acid; D008159:Lumbar Vertebrae / Q000737:chemistry; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D010281:Parathyroid Hormone / Q000097:blood; D010349:Patient Compliance; D018579:Patient Selection; D010384:Pelvic Bones / Q000737:chemistry; D010455:Peptides / Q000097:blood / Q000652:urine; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D024042:Collagen Type I; D004164:Diphosphonates; D010281:Parathyroid Hormone; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D015675:Osteocalcin; D003094:Collagen; D000077557:Ibandronic Acid