Method of administering bisphosphonates

Details Method of administering bisphosphonates Method of administering bisphosphonates

2001-06-18

2011-11-08

Azpuru, Carlos (Department: 1617)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Implant or insert

Reexamination Certificate

active

08052987

ABSTRACT:
The invention relates to bisphosphonates, in particular more potent N-bisphosphonates such as zoledronic acid and derivatives, and to methods of treatment using bisphosphonates. These bisphosphonates are used with satisfactory results for prolonged inhibition of bone resorption in conditions of abnormally increased bone turnover, e.g. osteoporosis, by intermittent administration, the periods between bisphosphonate administrations are longer than was previously considered appropriate, e.g. a dosing interval of at least about 6 months or less frequently.

REFERENCES:
patent: 4761406 (1988-08-01), Flora et al.
patent: 4812304 (1989-03-01), Anderson et al.
patent: 4812311 (1989-03-01), Uchtman
patent: 4822609 (1989-04-01), Flora
patent: 4939130 (1990-07-01), Jaeggi et al.
patent: 5366965 (1994-11-01), Strein
patent: 5616560 (1997-04-01), Geddes et al.
patent: 5730715 (1998-03-01), Sage, Jr. et al.
patent: 5965547 (1999-10-01), Goodship et al.
patent: 5994329 (1999-11-01), Daifotis et al.
patent: 6015801 (2000-01-01), Daifotis et al.
patent: 6225294 (2001-05-01), Daifotis et al.
patent: 6255288 (2001-07-01), Goodship et al.
patent: 2001/0001306 (2001-05-01), Daifotis et al.
patent: 2001/0002395 (2001-05-01), Daifotis et al.
patent: 2001/0018431 (2001-08-01), Daifotis et al.
patent: 2001/0044427 (2001-11-01), Mazel et al.
patent: 198 53 483 (1999-05-01), None
patent: 0 105 196 (1984-04-01), None
patent: 0 162 510 (1985-11-01), None
patent: 0 210 728 (1986-06-01), None
patent: 0 210 728 (1987-02-01), None
patent: 0 381 296 (1990-08-01), None
patent: 0600834 (1994-06-01), None
patent: 0 648 120 (1995-04-01), None
patent: 1 051 976 (2000-11-01), None
patent: 1 175 904 (2002-01-01), None
patent: 2 177 001 (1986-06-01), None
patent: 2 177 001 (1987-10-01), None
patent: 2 336 311 (1999-10-01), None
patent: A-62-048627 (1986-06-01), None
patent: WO 93/11786 (1993-06-01), None
patent: WO 96/07417 (1996-03-01), None
patent: WO 96/07418 (1996-03-01), None
patent: WO9712619 (1997-04-01), None
patent: WO 97/47356 (1997-12-01), None
patent: WO 98/57656 (1998-12-01), None
patent: WO 99/04773 (1999-02-01), None
patent: WO 99/15155 (1999-04-01), None
patent: WO 99/18972 (1999-04-01), None
patent: WO 00/71104 (2000-11-01), None
patent: WO 01/15703 (2001-03-01), None
patent: WO 01/45636 (2001-06-01), None
patent: WO0189494 (2001-11-01), None
patent: WO0197788 (2001-12-01), None
www.fda.gov/medwatch/safety/2008/Jun—PI/Reclast—PI.pdf.
J.J. Body, M.D., Ph.D., Cancer, vol. 80, Issue S8, pp. 1699-1701.
Hacking et al. “Disodium Pamidronate (AREDIA), Single Infusion Monotherapy (90 mg) Compared to Repeated Cycles of 30 mg for Symptomatic Treatment of Breast Cancer bone Metastases” Eur. J. Cancer, 27, Suppl. 2, S570, 1991.
Ryan et al, “Intravenous 3 Aminohydroxypropylidene 1.1 Biphosphonate (APD) in the Treatment of Pagets Disease”, Br. J. Rheumatol. (29, Abstr. Suppl. 2, 139, 1990).
Bombassei et al. “Effects of Intravenous Pamidronate Therapy on Paget's Disease of Bone”, The American Journal of American Sciences, vol. 308, No. 4, pp. 226-233, (1994).
H. Fleisch, “The Bisphosphonate Ibandronate, Given Daily as Well as Discontinuously, Decreases Bone Resorption and Increases Calcium Retention as Assessed by45Ca Kinetics in the Intact Rat”, Osteoporosis Int., vol. 6, pp. 166-170, (1996).
Roldan et al, “Clinical Application of Bisphosphonate's Pharmacokinetic Principles” Medicina, 57 Suppl 1 pp. 76-82, 1997 (English Translation of Aplicacion Clinica de los Principios Farmacocineticos de los Bisfosfonatos).
Filipponi et al., “Intermittent Versus Continuous Clodronate Administration in Postmenopausal Women with Low Bone Mass”, Bone, vol. 26, No. 3, pp. 269-274, (2000).
Boutsen et al, “Primary Prevention of Glucocorticoid-induced Osteoporosis with Intravenous Pamidronate and Calcium: a Prospective Controlled One-Year study Comparing a Single Infusion, a 3-Monthly Therapy and Calcium Alone”, Arthritis Rheum, vol. 43, No. 9, Suppl., S383 (2000).
Boutsen et al, “Primary Prevention of Glucocorticoid-Induced Osteoporosis with Intravenous Pamidronate and Calcium: A Prospective Controlled 1-Year Study Comparing a Single Infusion, an Infusion Given Once Every 3 Months, and Calcium Alone”, Journal of Bone and Mineral Research, vol. 16, No. 1, pp. 1-13 (2001).
Glorieux et al, “Cyclic Administration of Pamidronate in Children with Severe Osteogenesis lnperfecta”, The New England Journal of Medicine, vol. 339, No. 14, pp. 947-952, (2004).
Khan et al, “Comparison of Three Intravenous Regimens of Clodronate in Paget Disease of Bone”, Journal of Bone and Mineral Research, vol. 11, No. 2, pp. 178-182, (1996).
Pepersack et al, “Paget's Disease of Bone: Five Regimens of Pamidronate Treatment”, Clinical Rheumatology, vol. 13, No. 1, pp. 39-44, (1994).
Peretz et al, “Cyclical Pamidtronate Infusions in Postmenopausal Osteoporosis”, Maturitas: Journal of the Climacteric & PostMenopause, vol. 25, pp. 69-75, (1996).
Pfeilschifter et al., “Effect of Pamidronate on Clinical Symptoms and Bone Metabolisn in Fibrous Dysplasia and McCune-Albright-Syndrom”, Medizinische Klinik vol. 93, No. 6, pp. 352-359, (1998) (English translation of Wirkung von Pamidronat auf Beschwerdebild and Knochenstoffwechsel bei Bibroser Dysplasie McCune-Albright Symdrom).
Theibaud et al, “A Single Infusion of the Bisphosphonate AHPrBP (APD) as Treatment of Pagent's Disease of Bone”, The American Journal of Medicine, vol. 85, pp. 207-212 (1988).
Giannini et al., “Effects of One-Year Cyclical Treatment with Clodronate on Postmenopausal Bone Loss”,Bone, vol. 14, pp. 137-141 (1993).
Giannini et al., “Continuous and Cyclical Clodronate Therapies and Bone Density in Postmenopausal Bone Loss”,Obstet. Gynecol., vol. 88, No. 3, pp. 431-436 (1996).
Heikkinen et al., “Short-Term Intravenous Bisphosphonates in Prevention of Postmenopausal Bone Loss”,J. Bone Miner. Res., vol. 12, No. 1, pp. 103-110 (1997).
Lee et al., “Cyclic Pamidronate Infusion Improves Bone Mineralisation and Reduces Fracture Incidence in Osteogenesis Imperfecta”,Eur. J. Pediatr., vol. 160, No. 11, pp. 641-644 (2001).
Sorbera et al., “Zoledronate Disodium”,Drugs Fut., vol. 25, No. 3, pp. 259-268 (2000).
“Zoledronic Acid”,Adis R&D Insight(2000—abstract).
“Drug Updates”,R&D Focus(2000—abstract).
Storm et al., “Effect of Intermittent Cyclical Etidronate Therapy on Bone Mass and Fracture Rate in Women with Postmenopausal Osteoporosis”,NEJM, vol. 322, No. 18, pp. 1265-1271 (1990).
Watts et al., “Intermittent Cyclical Etidronate Treatment of Postmenopausal Osteoporosis”,NEJM, vol. 323, No. 2, pp. 73-79 (1990).
Lunar News Apr. 1997, p. 1-42.
M. Passeri (1991) “Intermittent treatment with intravenous 4-amino-1-hydroxyutylidene-1,1-bisphosphonate (AHBuBP) in the therapy of postmenopausal osteoporosis”Bone and Mineral, 15: 237-248.
S.D. Vasikaran et al. (1995) “Sustained Response to Intravenous Alendronate in Postmenopausal Osteoporosis”Bone17:6 517-520.
The Merck Manual, 1999, Chapter 59, Nonarticular Rheumatism, pp. 474-482.
Need, Allan G., et al. “Vitamin D Status: Effects on Parathyroid Hormone and 1,25-Dihydroxyvitamin D in Postmenopausal Women”; The American Journal of Clinical Nutrition, vol. 71, No. 6, Jun. 6, 2000; pp. 1577-1581.
Binkley, Neil, et al. “Zoledronate Prevents the Development of Absolute Osteopenia Following Ovariectomy in Adult Rhesus Monkeys”, Journal of Bone and Mineral Research, vol. 13, No. 11, 1998, pp. 1775-1782.
Body, J.J., et al. A Dose-Finding Study of Zoledronate in Hypercalcemic Cancer Patients, Journal of Bone and Mineral Research, vol. 14, No. 9, 1999, pp. 1557-1561.
Buckler, H., et al. “Single Infusion of Zoledronate in Paget's Disease of Bone: A Placebo-Controlled

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