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SAT0164 Two year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosisis
  1. R Rizzoli1,
  2. C Roux2,
  3. S Greenspan3,
  4. H Bone4,
  5. T Schnitzer5,
  6. N Watts6,
  7. S Adami7,
  8. B Uebelhart1,
  9. J Foldes8,
  10. C Peverly9,
  11. A Santora9,
  12. A Kaur9,
  13. M Wu9,
  14. J Orloff9 for the Alendronate Once-Weekly Study Group
  1. 1Department of Internal Medicine, Hôpital Cantonal, Geneva, Switzerland
  2. 2Hospital Cochin, Paris, France
  3. 3University of Pittsburgh, Pittsburgh, PA, USA
  4. 4Michigan Bone Clinic, Detroit, Michigan, USA
  5. 5Northwestern University, Chicago, IL, USA
  6. 6Emory University, Atlanta, GA, USA
  7. 7University of Verona, Verona, Italy
  8. 8Hadassah University Hospital, Jerusalem, Israel
  9. 9Merck Research Labs, Rahway, NJ, USA

Abstract

Background The therapeutic equivalence of alendronate (ALN) 70 mg once weekly (OW) (provided by Merck and Co., Inc., Whitehouse Station, NJ, USA), ALN 35 mg twice weekly (TW), and ALN 10 mg once daily (OD) in the treatment of postmenopausal osteoporosis for 1 year has been reported previously.1 We will present preliminary two-year BMD results from a one-year extension.

Methods We compared the efficacy of treatment with OW ALN 70 mg (n = 519), TW ALN 35 mg (n = 369), and OD ALN 10 mg (n = 370) over 2 years in a double-blind, multicenter study of postmenopausal women (age 40 to 90) with osteoporosis (BMD of either the lumbar spine or femoral neck ≥2.5 SDs below peak mean, or prior vertebral or hip fracture). The primary efficacy endpoint was change in lumbar spine BMD. Secondary endpoints included changes in BMD at the hip and total body.

Results Mean BMD increases at the lumbar spine, total hip, femoral neck, hip trochanter, and total body sites for each treatment regimen after two years were very similar, with no clinically meaningful differences.

Conclusion These findings confirm that once-weekly ALN 70 mg is therapeutically equivalent to once-daily ALN 10 mg in patients with postmenopausal osteoporosis. In addition, the two-year results demonstrate that once-weekly ALN 70 mg is generally as safe and well tolerated as ALN 10 mg once daily.

Reference

  1. Schnitzer, et al. Aging 2000;12:1–12

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