Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: results from the head-to-head MOTION study.
OBJECTIVE
Oral ibandronate 150 mg is the first bisphosphonate approved for once-monthly treatment of postmenopausal osteoporosis. To investigate whether once-monthly ibandronate 150 mg increases lumbar spine and total hip bone mineral density (BMD) to the same degree as weekly alendronate 70 mg.


METHODS
This was a 12-month, randomised, multinational, multicentre, double-blind, double-dummy, parallel-group, non-inferiority trial, conducted in 65 centres in North America, Latin America, Europe and South Africa. The study included postmenopausal women, mean lumbar spine (L2-L4) BMD T-score < -2.5 and > or = -5.0. Patients received either ibandronate 150 mg once monthly or alendronate 70 mg once weekly.


METHODS
Co-primary efficacy endpoints were 12-month change (%) from baseline in mean lumbar spine and total hip BMD. Changes (%) from baseline in trochanter and femoral neck BMD were also evaluated. Adverse events were monitored throughout. Once-monthly ibandronate was considered non-inferior to weekly alendronate if the lower boundary of the one-sided 97.5% confidence interval (CI) (or two-sided 95% CI) was > or = -1.41% for lumbar spine and > or = -0.87% for total hip.


RESULTS
Mean relative 12-month changes were 5.1% and 5.8% (95% CI for difference, -1.13, -0.23) in lumbar spine and 2.9% and 3.0% (95% CI for difference, -0.38, 0.18) in total hip BMD with once-monthly ibandronate and weekly alendronate, respectively; meeting the non-inferiority criteria at both sites. Gains in trochanter and femoral neck BMD were similar with both treatments. Both regimens were well tolerated.


BACKGROUND
The MOTION study is registered with the International Federation of Pharmaceutical Manufacturers and Associations trial portal, under the ID number MM17385.


CONCLUSIONS
Once-monthly ibandronate was shown to be clinically comparable to weekly alendronate at increasing BMD after 12 months in both the lumbar spine and total hip.
Colorado Center for Bone Research, Lakewood, Colorado 80227, USA. millerccbr@aol.com
Paul D
PD
Miller
Sol
S
Epstein
Farhad
F
Sedarati
Jean-Yves
JY
Reginster
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000008:administration & dosage* / Q000009:adverse effects; D000465:Algorithms; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid; D019386:Alendronate