Efficacy and safety of monthly ibandronate in men with low bone density.
Author(s): Orwoll ES, Binkley NC, Lewiecki EM, Gruntmanis U, Fries MA, Dasic G.
Affiliation(s): Oregon Health and Science University, Bone and Mineral Unit, Portland, OR 97239,
USA.
Publication date & source: 2010, Bone. , 46(4):970-6
INTRODUCTION: Monthly oral ibandronate is indicated for the prevention and
treatment of osteoporosis in postmenopausal women. The STudy Researching
Osteoporosis iN Guys (STRONG) investigated the efficacy and safety of 150-mg
monthly oral ibandronate in men with primary, idiopathic, or hypogonadism-related
low bone density.
METHODS: STRONG was a 1-year, placebo-controlled, randomized (2 ibandronate: 1
placebo), double-blind study that enrolled ambulatory men aged > or =30 years
with baseline femoral neck (FN) bone mineral density (BMD) T-scores < or =-2.0
and lumbar spine (LS) BMD T-scores < or =-1.0 or LS BMD T-scores < or =-2.0, FN
BMD T-scores < or =-1.0, and BMD T-scores > or =-4.0 at any site assessed by
dual-energy X-ray absorptiometry. The primary endpoint was mean percent change
from baseline in LS BMD at 1 year (intent-to-treat [ITT] population). Secondary
endpoints included mean BMD changes from baseline at the FN, total hip (TH), and
trochanter (TR) and changes in bone turnover markers (BTMs), as measured by the
bone resorption marker serum C-terminal telopeptide of type 1 collagen (sCTX) and
the bone formation marker bone-specific alkaline phosphatase (BSAP). All men
received twice daily calcium carbonate (1000 mg/day) and vitamin D (400 IU/day).
Changes in BMD for treatment groups were compared using analysis of covariance
with treatment, investigative site, and baseline testosterone as factors and
baseline BMD as a covariate.
RESULTS: The ITT population consisted of 132 men; 47 received placebo and 85
received monthly ibandronate. Men who received ibandronate achieved greater
increases in LS BMD at 12 months than those who received placebo (3.5% vs. 0.9%,
respectively; difference, 2.6; p<0.001). The ibandronate group also achieved
greater 12-month BMD increases than the placebo group, respectively, at the TH
(1.8% vs. -0.3%; difference, 2.1; p<0.001), FN (1.2% vs. -0.2%; difference, 1.4;
p=0.012), and TR (2.2% vs. 0.4%; difference, 1.7; p<0.005). In men who completed
the study and adhered to the protocol (per-protocol (PP) population), percent
decreases in median sCTX and BSAP levels from baseline were also greater with
ibandronate versus placebo (p< or =0.001 for both comparisons). Overall, monthly
ibandronate was well tolerated.
CONCLUSIONS: In men with low BMD, 1 year of treatment with oral once-monthly
150-mg ibandronate significantly increased BMD at the LS and hip (TH, TR, and
FN), significantly reduced BTM levels in the PP population, and was generally
well tolerated.
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