Efficacy and safety of monthly ibandronate in men with low bone density

Eric S. Orwoll; Neil C. Binkley; E. Michael Lewiecki; Ugis Gruntmanis; Michael A. Fries; Gorana Dasic

doi:10.1016/j.bone.2009.12.034

Efficacy and safety of monthly ibandronate in men with low bone density

Eric S. Orwoll
, Neil C. Binkley
, E. Michael Lewiecki
, Ugis Gruntmanis
, Michael A. Fries
, Gorana Dasic

Endocrinology, Diabetes and Clinical Nutrition

Research output: Contribution to journal › Article › peer-review

92 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	970-976
Number of pages	7
Journal	Bone
Volume	46
Issue number	4
DOIs	https://doi.org/10.1016/j.bone.2009.12.034
State	Published - Apr 1 2010

Funding

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.

Funders
GlaxoSmithKline
Roche

Keywords

Bone density
Ibandronate
Men
Osteoporosis
Treatment

ASJC Scopus subject areas

Endocrinology, Diabetes and Metabolism
Histology
Physiology

Access to Document

10.1016/j.bone.2009.12.034

Cite this

@article{ba72d376a22b4ddc93c9a48b3858f3ed,

title = "Efficacy and safety of monthly ibandronate in men with low bone density",

abstract = "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.",

keywords = "Bone density, Ibandronate, Men, Osteoporosis, Treatment",

author = "Orwoll, \{Eric S.\} and Binkley, \{Neil C.\} and Lewiecki, \{E. Michael\} and Ugis Gruntmanis and Fries, \{Michael A.\} and Gorana Dasic",

note = "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.",

year = "2010",

month = apr,

day = "1",

doi = "10.1016/j.bone.2009.12.034",

language = "English (US)",

volume = "46",

pages = "970--976",

journal = "Bone",

issn = "8756-3282",

publisher = "Elsevier Inc.",

number = "4",

}

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.

PY - 2010/4/1

Y1 - 2010/4/1

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

UR - https://www.scopus.com/pages/publications/77950545056

UR - https://www.scopus.com/pages/publications/77950545056#tab=citedBy

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 -

Efficacy and safety of monthly ibandronate in men with low bone density

Abstract

Funding

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this