Clinical trial of risedronate in Japanese volunteers: Single and multiple oral dose studies

Journal of Bone and Mineral Metabolism

Volumn 22, Issue 2, 2004, Pages 111-119

  Ogura, Yasuhiko ^a   Gonsho, Akinori ^a   Cyong, Jong Chol ^b   Orimo, Hajime ^c  

^a Pharmaceutical Company   (Japan)

^b UNIVERSITY OF TOKYO   (Japan)

^c Tokyo Metropolitan Institute of Gerontology   (Japan)

Author keywords

Bisphosphonate; NE 58095; Osteoporosis; Risedronate (risedronate sodium hydrate)

Indexed keywords

BETA 2 MICROGLOBULIN; CREATINE KINASE BB; DEOXYPYRIDINOLINE; RISEDRONIC ACID;

ADULT; AREA UNDER THE CURVE; ARTICLE; BETA 2 MICROGLOBULIN URINE LEVEL; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG TOLERABILITY; DRUG URINE LEVEL; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; JAPAN; LASSITUDE; MALAISE; MALE; MULTIPLE DRUG DOSE; NORMAL HUMAN; PAIN; PHARYNGITIS; PRIORITY JOURNAL; SIDE EFFECT; SINGLE DRUG DOSE; UNITED KINGDOM;

ADMINISTRATION, ORAL; ADULT; AREA UNDER CURVE; CALCIUM CHANNEL BLOCKERS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; ETIDRONIC ACID; GREAT BRITAIN; HUMANS; JAPAN; MALE; MIDDLE AGED; MOLECULAR STRUCTURE; OSTEOPOROSIS; URINE;

EID: 1642504772     PISSN: 09148779     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00774-003-0458-y     Document Type: Article

References (13)

1. Orimo H, Ohta H, Kishimoto H, Shiraki M, Suzuki T, Takaoka K, Nakamura T, Nishizawa Y, Hagino H, Hayashi Y, Hirota T, Fukunaga M, Hosoi T, Matsumoto T, Miki T, Yoh K, Wada S (2002) Guidelines for the treatment (pharmacotherapy) of osteoporosis: year 2000 revision (in Japanese). Osteoporosis Jpn 10:635-709
2. Orimo H, Hayashi Y, Fukunaga M, Sone T, Fujiwara S, Shiraki M, Kushida K, Miyamoto S, Soen S, Nishimura J, Oh-hashi Y, Hosoi T, Gorai I, Tanaka H, Igai T, Kishimoto H (2001) Diagnostic criteria for primary osteoporosis: year 2000 revision. J Bone Miner Metab 19:331-337
3. Nishizawa Y, Nakamura T, Ohata H, Kushida K, Gorai I, Shiraki M, Fukunaga M, Hosoi T, Miki T, Nakatsuka K, Miura M (2001) Guidelines on the use of biochemical markers of bone turnover in osteoporosis (2001). J Bone Miner Metab 19:338-344
4. Kawashima H (1993) Specificity of bisphosphonates' effect and bone metabolism. In: Fujita T (ed) Osteoporosis: diagnosis and treatment (in Japanese). Life Science Publishing, Tokyo, pp 397-408
5. Sietsema WK, Ebetino FH, Salvagno AM, Bevan JA (1989) Antiresorptive dose-response relationships across three generations of bisphosphonates. Drugs Exp Clin Res 15:389-396
6. Watts NB, Harris ST, Genant HK, Wasnich RD, Miller PD, Jackson RD, Licata AA, Ross P, Woodson GC, Yanover MJ, Mysiw WJ, Kohse L, Rao MB, Steiger P, Richmond B, Chesnut CH III (1990) Intermittent cyclical etidronate treatment of postmenopausal osteoporosis. N Engl J Med 323:73-79
7. Fujita T, Orimo H, Inoue T, Kaneda K, Sakurai M, Morita R, Morii H, Yamamoto K, Sugioka Y, Inoue A, Hoshino Y, Kawaguchi H, Yamamoto I, Fukase M, Takaoka K (1993) Double-blind multicenter comparative study with alfacalcidol of etidronate disodium (EHDP) in involutional osteoporosis (in Japanese). Clin Eval 21:261-302
8. Liberman UA, Weiss SR, Bröll J, Minne HW, Quan H, Bell NH, Rodriguez-Portales J, Downs RW, Dequeker J, Favus M, Seeman E, Recker RR, Capizzi T, Santora AC, Lombardi A, Shah RV, Hirsch LJ, Karpf DB (1995) Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 333:1437-1444
9. Shiraki M, Kushida K, Fukunaga M, Kishimoto H, Kaneda K, Minaguchi H, Inoue T, Tomita A, Nagata Y, Nakashima M, Orimo H (1998) A placebo controlled, single-blind study to determine the appropriate alendronate dosage in postmenopausal Japanese patients with osteoporosis. Endocr J 45:191-201
10. Mitchell DY, Eusebio RA, Sacco-Gibson NA, Pallone KA, Kelly SC, Nesbitt JD, Brezovic CP, Thompson GA, Powell JH (2000) Dose-proportional pharmacokinetics of risedronate on single-dose oral administration to healthy volunteers. J Clin Pharmacol 40:258-265
11. DeSilva BS, Whitham DJ, Bhullar B, Kamra LC, DeStefano AJ (1998) Validation of an enzyme linked immunosorbent assay for the determination of risedronate in human serum. AAPS PharmSci 1:S26. http://www.aapspharmsci.org/
12. Gropp KE, Bouchard GF, Phipps RJ, Smith PN (1997) Risedronate dose-dependently decreases bone turnover in ovariectomized minipigs. J Bone Miner Res 12 (suppl 1):S471
13. Fleisch H (2000) Bisphosphonates in Bone Disease, 4th edn. Academic Press, San Diego, pp 56-57