Efficacy and safety of a once-yearly i.v. infusion of zoledronic acid 5mg versus a once-weekly 70-mg oral alendronate in the treatment of male osteoporosis: A randomized, multicenter, double-blind, active-controlled study

Journal of Bone and Mineral Research

Volumn 25, Issue 10, 2010, Pages 2239-2250

  Orwoll, Eric S ^a   Miller, Paul D ^b   Adachi, Jonathan D ^c   Brown, Jacques ^d   Adler, Robert A ^e   Kendler, David ^f   Bucci Rechtweg, Christina ^g   Readie, Aimee ^g   Mesenbrink, Peter ^g   Weinstein, Robert S ^h  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b University of Colorado Health Sciences Center   (United States)

^c MCMASTER UNIVERSITY   (Canada)

^d LAVAL UNIVERSITY   (Canada)

^e VETERANS AFFAIRS MEDICAL CENTER   (United States)

^f Prohealth Clinical Research   (Canada)

^g NOVARTIS PHARMA AG   (Switzerland)

^h UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

Author keywords

Alendronate; Bone mineral density; Bone turnover markers; Male osteoporosis; Zoledronic acid

Indexed keywords

ALENDRONIC ACID; ALKALINE PHOSPHATASE BONE ISOENZYME; AMINO TERMINAL PROPEPTIDE; AMINO TERMINAL TELOPEPTIDE; CALCIUM; CARBOXY TERMINAL TELOPEPTIDE; COLLAGEN TYPE 1; PLACEBO; UNCLASSIFIED DRUG; VITAMIN D; ZOLEDRONIC ACID;

ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BONE DENSITY; BRAIN INFARCTION; BRAIN STEM INFARCTION; CEREBROVASCULAR ACCIDENT; CHILL; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CREATININE BLOOD LEVEL; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EYE DISEASE; FATIGUE; FEMUR; FEMUR NECK; FEVER; FLU LIKE SYNDROME; GASTROESOPHAGEAL REFLUX; HEADACHE; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HIP; HUMAN; HYPERTENSION; HYPOCALCEMIA; JAW OSTEONECROSIS; LIMB PAIN; LUMBAR SPINE; MAJOR CLINICAL STUDY; MALAISE; MALE; MALE OSTEOPOROSIS; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; MYALGIA; OSTEOLYSIS; OSTEOPOROSIS; PAIN; PATIENT COMPLIANCE; PROTEIN BLOOD LEVEL; PROTEIN URINE LEVEL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SINUSITIS; TRANSIENT ISCHEMIC ATTACK; UPPER RESPIRATORY TRACT INFECTION;

AGED; ALENDRONATE; BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; HUMANS; IMIDAZOLES; MALE; MIDDLE AGED; OSTEOPOROSIS; TREATMENT OUTCOME;

EID: 77954258511     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1002/jbmr.119     Document Type: Article

References (24)

1. Orwoll E, Ettinger M, Weiss S, et al. Alendronate for the treatment of osteoporosis in men. N Engl J Med. 2000;343:604-610.
2. Cummings SR, Melton LJ. Epidemiology and outcomes of osteoporotic fractures. Lancet. 2002;18:1761-1767.
3. Melton LJ III, Cooper C. Magnitude and impact of osteoporosis and fractures. In: Marcus R, Feldman D, Kelsey J, eds. Osteoporosis. 2nd ed. Vol. 1 San Diego: Academic Press; 2001:557-567.
4. Binkley N. Osteoporosis in men. Arq Bras Endocrinol Metab. 2006;50: 764-774.
5. Kamel HK. Male osteoporosis: new trends in diagnosis and therapy. Drugs Aging. 2005;22:741-748.
6. Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996; 348:1535-1541.
7. Ho YV, Frauman AG, Thomson W, Seeman E. Effects of alendronate on bone density in men with primary and secondary osteoporosis. Osteoporos Int. 2000;11:98-101. (Pubitemid 30168794)
8. Adami S, Prizzi R, Colapietro F. Alendronate for the treatment of osteoporosis in men. Calcif Tissue Int. 2001;69:239-241.
9. Weber TJ, Drezner MK. Effect of alendronate on bone mineral density in male idiopathic osteoporosis. Metabolism. 2001;50:912-915.
10. Gonnelli S, Cepollaro C, Montagnani A, et al. Alendronate treatment in men with primary osteoporosis: a three-year longitudinal study. Calcif Tissue Int. 2003;73:133-139.
11. Boonen S, Orwoll ES, Wenderoth D, Stoner KJ, Eusebio R, Delmas PD. Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study. J Bone Miner Res. 2009;24:719-725.
12. Black DM, Delmas PD, Eastell R, et al. HORIZON Pivotal Fracture Trial Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;358:1809-1822.
13. McClung M, Recker R, Miller PM, et al. Intravenous zoledronic acid 5mg in the treatment of postmenopausal women with low bone density previously treated with alendronate. Bone. 2007;41:122-128.
14. Lenchik L, Rogers LF, Delmas PD, Genant HK. Diagnosis of osteoporotic vertebral fractures: importance of recognition and description by radiologists. AJR Am J Roentgenol. 2004;R183:949-958.
15. Leslie WD. Factors affecting short-term bone density precision assessment and the effect on patient monitoring. J Bone Miner Res. 2008;23:199-204.
16. Hangartner TN. A study of the long-term precision of dual-energy Xray absorptiometry bone densitometers and implications for the validity of the least-significant-change calculation. Osteoporos Int. 2007;18:513-523.
17. Christiansen C, Tankó LB, Warming L, et al. Dose dependent effects on bone resorption and formation of intermittently administered intravenous ibandronate. Osteoporos Int. 2003;14:609-613.
18. Lyles KW, Colón-Emeric CS, Magaziner JS, et al. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med. 2007;357:1799-1809.
19. Boonen S, Sellmeyer DE, Lippuner K, et al. Renal safety of annual zoledronic acid infusions in osteoporotic postmenopausal women. Kidney Int. 2008;74:641-648.
20. Rhim SY, Park J-H, Park Y-S, et al. Bioavailability and bioequivalence of two oral formulations of alendronate sodium 70mg: an open-label, randomized, two-period crossover comparison in healthy Korean adult male volunteers. Clinical Therapeutics. 2009;31:1037-1045.
21. Gertz BJ, Holland SD, Kline WF, Matuszewski BK, Porras AG. Clinical Pharmacology of Alendronate Sodium B. Osteoporosis Int Suppl. 1993;3:S13-16.
22. Bukata SV, Healey JH. Bisphosphonates: a practical guide. Curr Opin Orthop. 2004;15:376-377.
23. Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005;21: 1453-1460.
24. Siris ES, Harris ST, Rosen CJ, et al. Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clinic Proceedings. 2006;81:1013-1022.