TY - JOUR
T1 - Efficacy and safety of monthly ibandronate in men with low bone density
AU - Orwoll, Eric S.
AU - Binkley, Neil C.
AU - Lewiecki, E. Michael
AU - Gruntmanis, Ugis
AU - Fries, Michael A.
AU - Dasic, Gorana
N1 - Funding Information:
The following investigators participated in this study: R. Ackerman, Comprehensive Clinical Trials LLC, West Palm, FL; RA Adler, Richmond Virginia Medical Center, Richmond, VA; R. Bernstein, Marine Endocrine Care and Research Inc., Greenbrae, CA; R. Bhattacharya, University of Kansas Medical Center, Kansas City, KS; N. Binkley, University of Wisconsin Osteoporosis Clinical Center and Research Program, Madison, WI; M. Bolognese, Bethesda Health Research, Bethesda, MD; M. Greenwald, Desert Medical Advances, Palm Desert, CA; U. Gruntmanis, Dallas Veterans Affairs Medical Center and University of Texas Southwestern Medical Center, Dallas, TX; S. Hippler, OSF Medical Group Clinical, Peoria, IL; A. Iranmanesh, Salem Veterans Medical Center, Salem, VA; R. Khairi, Physicians Research Group, Indianapolis, IN; A. Kivitz, Altoona Center for Clinical Research, Duncansville, PA; G. Ledger, St. John's Medical Clinic-Research, Springfield, MO; S. Levis-Dusseau, VA Medical Center Miami, Miami, FL; E.M. Lewiecki, New Mexico Clinical Research and Osteoporosis Center Inc., Albuquerque, NM; M. Maricic, Catalina Pointe Clinical Research Inc., Tucson, AZ; D. Podlecki, Longmont Medical Research Network, Longmont, CO; C. Recknor, United Osteoporosis Centers, Gainesville, GA; R. Rosenberg, The Center for Rheumatology and Bone Research, Wheaton, MD; K. Saag, The University of Alabama at Birmingham, Birmingham, AL; W. Saikali, Rheumatology and Pulmonary Clinic, Beckley, WV; E. Schwartz, Northern California Institute for Bone Health Inc., Oakland, CA; A. Sebba, Arthritis Research of Florida Inc., Palm Harbor, FL; A. Shields, Puget Sound Osteoporosis Center, Seattle, WA; S. Silverman, Osteoporosis Medical Center, Beverly Hills, CA; J. Tucci, Roger Williams Medical Center Bone and Mineral Unit, Providence, RI; C Vanek, Oregon Health and Science University Bone and Mineral Unit, Portland, OR; J. Vargo, Asheville Arthritis and Osteoporosis, Asheville, NC; R. Weinstein, Diablo Clinical Research, Walnut Creek, CA; and G. Woodson, Atlanta Research Center, Decatur, GA. This study was supported and funded by Roche and GlaxoSmithKline. The authors would like to acknowledge the writing assistance of Rebecca Jarvis, PhD, of Envision Scientific Solutions, Southport, CT, in the preparation of this manuscript.
Funding Information:
Dr. Orwoll has received research support from Lilly and Amgen and is a consultant for Lilly, Merck, GTX, and Amgen. Dr. Binkley has received research grants from Aventis, Deltanoid, GlaxoSmithKline, Roche, Novartis, and Merck; is a consultant/speaker for Merck, Lilly, Novartis, and Roche; and has received honoraria from GlaxoSmithKline, Lilly, Merck, Novartis, Procter and Gamble, and Roche. Dr. Lewiecki has received research grants and/or honoraria from Amgen, GlaxoSmithKline, Eli Lilly, Novartis, Procter and Gamble, and Roche and is a consultant/speaker for Amgen, GlaxoSmithKline, Eli Lilly, Novartis, Procter and Gamble, and Roche. Dr. Gruntmanis has received research grants from Roche and Novartis. Dr. Fries is an employee of GlaxoSmithKline. Dr. Dasic is an employee of GlaxoSmithKline.
Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2010/4
Y1 - 2010/4
N2 - 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 > 30 years with baseline femoral neck (FN) bone mineral density (BMD) T-scores << 2.0 and lumbar spine (LS) BMD T-scores << 1.0 or LS BMD T-scores << 2.0, FN BMD T-scores << 1.0, and BMD T-scores >> 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<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.
AB - 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 > 30 years with baseline femoral neck (FN) bone mineral density (BMD) T-scores << 2.0 and lumbar spine (LS) BMD T-scores << 1.0 or LS BMD T-scores << 2.0, FN BMD T-scores << 1.0, and BMD T-scores >> 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<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.
KW - Bone density
KW - Ibandronate
KW - Men
KW - Osteoporosis
KW - Treatment
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U2 - 10.1016/j.bone.2009.12.034
DO - 10.1016/j.bone.2009.12.034
M3 - Article
C2 - 20060082
AN - SCOPUS:77950545056
SN - 8756-3282
VL - 46
SP - 970
EP - 976
JO - Bone
JF - Bone
IS - 4
ER -