Major clinical trials

Black DM. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996;348(9041):1535-41.

Cummings SR. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. Jama 1998;280(24):2077-82.

Pols HAP. Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: Results of the FOSIT study. Osteoporosis International 1999;9(5):461-8.

Liberman UA. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995;333(22):1437-43.

Ravn P. Alendronate in early postmenopausal women: effects on bone mass during long-term treatment and after withdrawal. Alendronate Osteoporosis Prevention Study Group. J Clin Endocrinol Metab 2000;85(4):1492-7.

Bell NH. Alendronate increases bone mass and reduces bone markers in postmenopausal African-American women. J Clin Endocrinol Metab 2002;87(6):2792-7.

Drake WM. An investigation of the predictors of bone mineral density and response to therapy with alendronate in osteoporotic men. J Clin Endocrinol Metab 2003;88:5759-65.

Gonnelli S. Alendronate treatment in men with primary osteoporosis: a three-year longitudinal study. Calcif Tissue Int 2003;73:133-9.

McClung MR. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 2001;344:333-40.

Reginster J. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 2000;11(1):83-91.

Stakkestad JA. Intravenous ibandronate injections given every three months: a new treatment option to prevent bone loss in postmenopausal women. Ann Rheum Dis 2003;62:969-75.

Adami S. Efficacy and safety of ibandronate given by intravenous injection once every 3 months. Bone 2004;34:881-9.

Recker R. Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis. Bone 2004;34:890-9.

Delmas PD. Intravenous ibandronate injections in postmenopausal women with osteoporosis: One-year results from the dosing intravenous administration study. Arthritis Rheum 2006;54(6):1838-46.

Reginster JY. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann Rheum Dis 2006;65(5):654-61.

Chesnut C. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004;19(8):1241-9.

Black DM. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356(18):1809-22.


Fratzl P. Effects of sodium fluoride and alendronate on the bone mineral in minipigs: a small-angle X-ray scattering and backscattered electron imaging study. J Bone Miner Res 1996;11(2):248-53.

Chavassieux PM. Histomorphometric assessment of the long-term effects of alendronate on bone quality and remodeling in patients with osteoporosis. J Clin Invest 1997;100(6):1475-80.

Boivin GY. Alendronate increases bone strength by increasing the mean degree of mineralization of bone tissue in osteoporotic women. Bone 2000;27:687-94.

Mashiba T. Effects of suppressed bone turnover by bisphosphonates on microdamage accumulation and biomechanical properties in clinically relevant skeletal sites in beagles. Bone 2001;28:524-31.

Eriksen EF. Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis. Bone 2002;31:620-5.

Hill JA. Progression of coronary artery calcification in patients taking alendronate for osteoporosis. Acad Radiol 2002;9(10):1148-52.

Bauer DC. Change in bone turnover and hip, non-spine, and vertebral fracture in alendronate-treated women: the fracture intervention trial. J Bone Miner Res 2004;19(8):1250-8.

Recker RR. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporos Int 2004;15:231-7. Epub 2004 Jan 16.

Tanko LB. Effective doses of ibandronate do not influence the 3-year progression of aortic calcification in elderly osteoporotic women. Osteoporos Int 2004;10:10.

Hordon LD. Preservation of thoracic spine microarchitecture by alendronate: comparison of histology and microCT. Bone 2006;38(3):444-9.

Shimshi M. Bisphosphonates induce inflammation and rupture of atherosclerotic plaques in apolipoprotein-E null mice. Biochem Biophys Res Commun 2005;328(3):790-3.

Allen MR. Alterations in canine vertebral bone turnover, microdamage accumulation, and biomechanical properties following 1-year treatment with clinical treatment doses of risedronate or alendronate. Bone 2006;39(4):872-9.

Borah B. Long-term risedronate treatment normalizes mineralization and continues to preserve trabecular architecture: sequential triple biopsy studies with micro-computed tomography. Bone 2006;39(2):345-52.

Bauer DC. Pretreatment levels of bone turnover and the antifracture efficacy of alendronate: the fracture intervention trial. J Bone Miner Res 2006;21(2):292-9.


Rodan GA. Bisphosphonates: mechanisms of action. J Clin Invest 1996;97(12):2692-6.

Rogers MJ. New insights into the molecular mechanisms of action of bisphosphonates. Curr Pharm Des 2003;9:2643-58.

Russell RG. Bisphosphonates: from bench to bedside. Ann N Y Acad Sci 2006;1068:367-401.

Luckman SP. Nitrogen-containing bisphosphonates inhibit the mevalonate pathway and prevent post-translational prenylation of GTP-binding proteins, including Ras. J Bone Miner Res 1998;13(4):581-9.

van Beek ER. Binding and antiresorptive properties of heterocycle-containing bisphosphonate analogs: structure-activity relationships. Bone 1998;23(5):437-42.

Fisher JE. Alendronate mechanism of action: geranylgeraniol, an intermediate in the mevalonate pathway, prevents inhibition of osteoclast formation, bone resorption, and kinase activation in vitro. Proc Natl Acad Sci U S A 1999;96(1):133-8.


van Persijn van Meerten EL. Epi- and metaphyseal changes in children caused by administration of bisphosphonates. Radiology 1992;184(1):249-54.

Speiser PW. Bisphosphonate treatment of pediatric bone disease. Pediatr Endocrinol Rev 2005;3(2):87-96.

Land C. Cyclical intravenous pamidronate treatment affects metaphyseal modeling in growing patients with osteogenesis imperfecta. J Bone Miner Res 2006;21(3):374-9.

Rauch F. Long-bone changes after pamidronate discontinuation in children and adolescents with osteogenesis imperfecta. Bone 2007;40(4):821-7.

Long term

Bone HG. Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 2004;350:1189-99.

Ensrud KE. Randomized trial of effect of alendronate continuation versus discontinuation in women with low BMD: results from the Fracture Intervention Trial long-term extension. J Bone Miner Res 2004;19(8):1259-69.

Black DM. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. Jama 2006;296(24):2927-38.

Armamento-Villareal R. Suppressed bone turnover during alendronate therapy for high-turnover osteoporosis. N Engl J Med 2006;355(19):2048-50.

Liberman UA. Long-term safety of bisphosphonate therapy for osteoporosis: a review of the evidence. Drugs Aging 2006;23(4):289-98.

Odvina CV. Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab 2005;90(3):1294-301.

Ott SM. Long-term safety of bisphosphonates. J Clin Endocrinol Metab 2005;90(3):1897-9.

Fracture healing

Peter CP. Effect of alendronate on fracture healing and bone remodeling in dogs. J Orthop Res 1996;14:74-9.

Adolphson P. Clodronate increases mineralization of callus after Colles' fracture: a randomized, double-blind, placebo-controlled, prospective trial in 32 patients. Acta Orthop Scand 2000;71(2):195-200.

Li C. Long-term effect of incadronate disodium (YM-175) on fracture healing of femoral shaft in growing rats. J Bone Miner Res 2001;16:429-36.

Venesmaa PK. Alendronate reduces periprosthetic bone loss after uncemented primary total hip arthroplasty: a prospective randomized study. J Bone Miner Res 2001;16:2126-31.

Agarwala S. Alendronate in the treatment of avascular necrosis of the hip. Rheumatology (Oxford) 2002;41(3):346-7.

Cao Y. Raloxifene, estrogen, and alendronate affect the processes of fracture repair differently in ovariectomized rats. J Bone Miner Res 2002;17:2237-46.

van der Poest Clement E. Alendronate in the prevention of bone loss after a fracture of the lower leg. J Bone Miner Res 2002;17(12):2247-55.

Huang RC. Alendronate inhibits spine fusion in a rat model. Spine 2005;30(22):2516-22.

Xue Q. The influence of alendronate treatment and bone graft volume on posterior lateral spine fusion in a porcine model. Spine 2005;30(10):1116-21.

Arabmotlagh M. Alendronate prevents femoral periprosthetic bone loss following total hip arthroplasty: prospective randomized double-blind study. J Orthop Res 2006;24(7):1336-41.

Shetty N. Clinical and radiological outcome of total hip replacement five years after pamidronate therapy. A trial extension. J Bone Joint Surg Br 2006;88(10):1309-15.

Wang CJ. Three-year changes in bone mineral density around the knee after a six-month course of oral alendronate following total knee arthroplasty. A prospective, randomized study. J Bone Joint Surg Am 2006;88(2):267-72.


Ott SM. Clinical effects of bisphosphonates in involutional osteoporosis. J Bone Miner Res 1993;8 Suppl 2:S597-606.

Schousboe JT. Cost-effectiveness of alendronate therapy for osteopenic postmenopausal women. Ann Intern Med 2005;142(9):734-41.

Updated 6/3/07