Therapeutic equivalence of alendronate 35 milligrams once weekly and 5 milligrams daily in the prevention of postmenopausal osteoporosis

Obstetrics and Gynecology

Volumn 101, Issue 4, 2003, Pages 711-721

  Luckey, Marjorie M ^a   Gilchrist, Nigel ^b   Bone, Henry G ^b   Davie, Michael W ^b   De Villiers, Tobias J ^b   Wu, Mei ^b   Daifotis, Anastasia G ^b   Santora, Arthur C ^b   Orloff, John J ^b  

^a St Barnabas Ambulatory Care Center   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BONE DENSITY; BONE MINERAL; BONE TURNOVER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; ESOPHAGITIS; FEMALE; FEMUR NECK; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HUMAN; LUMBAR SPINE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NAUSEA; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STOMACH ULCER; UPPER GASTROINTESTINAL TRACT;

EID: 0037381072     PISSN: 00297844     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0029-7844(03)00008-5     Document Type: Article

References (28)

1. Chrischilles E.A., Butler C.D., Davis C.S., Wallace R.B. A model of lifetime osteoporosis impact. Arch Intern Med. 151:1991;2026-2032.
2. Melton L.J. III, Chrischilles E.A., Cooper C., Lane A.W., Riggs B.L. How many women have osteoporosis? J Bone Miner Res. 7:1992;1005-1010.
3. Ross P.D., Davis J.W., Epstein R.S., Wasnich R.D. Pre-existing fractures and bone mass predict vertebral fracture incidence in women. Ann Intern Med. 114:1991;919-923.
4. Gehlbach S.H., Fournier M., Bigelow C. Recognition of osteoporosis by primary care physicians. Am J Public Health. 92:2002;271-273.
5. Seedor J.G., Quartuccio H.A., Thompson D.D. The bisphosphonate alendronate (MK-217) inhibits bone loss due to ovariectomy in rats. J Bone Miner Res. 6:1991;339-346.
6. Balena R., Toolan B.C., Shea M., Markatos A., Myers E.R., Lee S.C., et al. The effects of 2-year treatment with the aminobisphosphonate alendronate on bone metabolism, bone histomorphometry, and bone strength in ovariectomized nonhuman primates. J Clin Invest. 92:1993;2577-2586.
7. Rodan G.A., Seedor J.G., Balena R. Preclinical pharmacology of alendronate. Osteoporos Int. 3:(Suppl 3):1993;S7-S12.
8. Khan S.A., Kanis J.A., Vasikaran S., Kline W.F., Matuszewski B.K., McCloskey E.V., et al. Elimination and biochemical responses to intravenous alendronate in postmenopausal osteoporosis. J Bone Miner Res. 12:1997;1700-1707.
9. Gertz B.J., Holland S.D., Kline W.F., Matuszewski B.K., Porras A.G. Clinical pharmacology of alendronate sodium. Osteoporos Int. 3:(Suppl 3):1993;S13-S16.
10. Porras A.G., Holland S.D., Gertz B.J. Pharmacokinetics of alendronate. Clin Pharmacokinet. 36:1999;315-328.
11. Tucci J.R., Tonino R.P., Emkey R.D., Peverly C.A., Kher U., Santora A.C. Effect of three years of oral alendronate treatment in postmenopausal women with osteoporosis. Am J Med. 101:1996;488-501.
12. Chesnut C.H. 3rd, McClung M.R., Ensrud K.E., Bell N.H., Genant H.K., Harris S.T., et al. Alendronate treatment of the postmenopausal osteoporotic woman Effect of multiple dosages on bone mass and bone remodeling . Am J Med. 99:1995;144-152.
13. Lufkin E.G., Argueta R., Whitaker M.D., Cameron A.L., Wong V.H., Egan K.S., et al. Pamidronate An unrecognized problem in gastrointestinal tolerability . Osteoporos Int. 4:1994;320-322.
14. Peter C.P., Handt L.K., Smith S.M. Esophageal irritation due to alendronate sodium tablets Possible mechanisms . Dig Dis Sci. 43:1998;1998-2002.
15. Bone H.G., Adami S., Rizzoli R., Favus M., Ross P.D., Santora A., et al. Weekly administration of alendronate Rationale and plan for clinical assessment . Clin Ther. 22:2000;15-28.
16. Schnitzer T., Bone H.G., Crepaldi G., Adami S., McClung M., Kiel D., et al. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Aging Clin Exp Res. 12:2000;1-12.
17. Genant H.K., Wu C.Y., Van Kuijk C., Nevitt M.C. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 8:1993;1137-1148.
18. Faulkner K.G., McClung M.R. Quality control of DXA instruments in multicenter trials. Osteoporos Int. 5:1995;218-227.
19. McClung M., Clemmesen B., Daifotis A., Gilchrist N.L., Eisman J., Weinstein R.S., et al. Alendronate prevents postmenopausal bone loss in women without osteoporosis A double-blind, randomized, controlled trial . Ann Intern Med. 128:1998;253-261.
20. Hosking D., Chilvers C.E., Christiansen C., Ravn P., Wasnich R., Ross P., et al. Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. N Engl J Med. 338:1998;485-492.
21. Jones B., Jarvis P., Lewis J.A., Ebbutt A.F. Trials to assess equivalence The importance of rigorous methods . BMJ. 313:1996;36-39.
22. Garnero P., Sornay-Rendu E., Delmas P.D. Decreased bone turnover in oral contraceptive users. Bone. 16:1995;499-503.
23. Liberman U.A., Weiss S.R., Broll J., Minne H.W., Quan H., Bell N.H., et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med. 333:1995;1437-1443.
24. Bailey J.E., Lee M.D., Somes G.W., Graham R.L. Risk factors for antihypertensive medication refill failure by patients under medicaid managed care. Clin Ther. 18:1996;1252-1262.
25. Hamilton R.A., Briceland L.L. Use of prescription-refill records to assess patient compliance. Am J Hosp Pharm. 49:1992;1691-1696.
26. Sbarbaro J.A. Strategies to improve compliance with therapy. Am J Med. 79:1985;34-37.
27. Simon J.A., Lewiecki E.M., Smith M.E., Petruschke R.A., Wang L., Palmisano J.J. Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: A multicenter, randomized, open-label, crossover study. Clin Ther. 24:2002;1871-1886.
28. Claxton A., de Klerk E., Parry M., Robinson J.M., Schmidt M.E. Patient compliance to a new enteric-coated weekly formulation of fluoxetine during continuation treatment of major depressive disorder. J Clin Psychiatry. 61:2000;928-932.