The Alendronate Once-Weekly Study Group Authors: Rizzoli R (corresponding author), Greenspan SL, Bone G III, Schnitzer TJ, Watts NB, Adami S, Foldes AJ, Roux C, Levine MA, Uebelhart B, Santora AC II, Kaur A, Peverly CA, and Orloff JJ.
Two-Year Results of Once-Weekly Administration of Alendronate 70 mg for the Treatment of Postmenopausal Osteoporosis
Article first published online: 1 NOV 2002
Copyright © 2002 ASBMR
Journal of Bone and Mineral Research
Volume 17, Issue 11, pages 1988–1996, November 2002
How to Cite
Rizzoli, R. (2002), Two-Year Results of Once-Weekly Administration of Alendronate 70 mg for the Treatment of Postmenopausal Osteoporosis. J Bone Miner Res, 17: 1988–1996. doi: 10.1359/jbmr.2002.17.11.1988
For list of participating investigators and clinical centers see Appendix.
Dr. Bone serves as a consultant for Merck. Dr. Greenspan serves as a speaker for Merck. Dr. Kaur has financial interests in corporate appointments and stock ownership in Merck. Dr. Levine speaks for Lilly, Merck, and Procter and Gamble. Dr. Orloff is a Merck employee. Ms. Peverly is a Merck employee has stock ownership and stock options. Dr. Rizzoli is a speaker for Merck. Dr. Santora is a Merck employee and has financial interests in stock ownership and stock options. Dr. Schnitzer serves as a consultant for Lilly, Merck and Co., Inc., Novartis, and Wyeth-Ayerst. He also receives clinical research support from Lilly, Merck and Co., Inc., Novartis, Pfizer, Proctor and Gamble, and Wyeth-Ayerst. In addition, Dr. Schnitzer speaks for Lilly, Merck and Co., Inc., and Wyeth-Ayerst. Dr. Watts receives an honorarium for speaking for Merck. All other authors have no conflict of interest.
- Issue published online: 2 DEC 2009
- Article first published online: 1 NOV 2002
- Manuscript Accepted: 31 MAY 2002
- Manuscript Revised: 15 MAR 2002
- Manuscript Received: 28 DEC 2001
- once-weekly dosing;
- bone mass;
The aim of this study was to provide confirmation that once-weekly dosing with 70 mg of alendronate (seven times the daily oral dose) and twice-weekly dosing with 35 mg is equivalent to the 10-mg once-daily regimen and to gain more extensive safety experience with this new dosing regimen. Twelve hundred fifty-eight postmenopausal women (aged 42–95 years) with osteoporosis (bone mineral density [BMD] of either lumbar spine or femoral neck at least 2.5 SDs below peak young adult mean or prior vertebral or hip fracture) were assigned to receive oral once-weekly alendronate, 70 mg (n = 519); twice-weekly alendronate, 35 mg (n = 369); or daily alendronate 10 mg (n = 370) for a total of 2 years of double-blind experience. Mean BMD increases from baseline (95% CI) at 24 months in the once-weekly, twice-weekly, and daily treatment groups, respectively, were 6.8% (6.4, 7.3), 7.0% (6.6, 7.5), and 7.4% (6.9, 7.8) at the lumbar spine and 4.1% (3.8, 4.5), 4.3% (3.9, 4.7), and 4.3% (3.9, 4.7) at the total hip. These increases in BMD as well as the BMD increases at the femoral neck, trochanter, and total body and the reductions of biochemical markers of bone resorption (urinary cross-linked N-telopeptides of type I collagen [NTx]) and bone formation (serum bone-specific alkaline phosphatase [BSAP]) were similar for the three dosing regimens. All treatment regimens were well tolerated with a similar incidence of upper gastrointestinal (GI) adverse experiences. The incidence rates of clinical fractures, captured as adverse experiences, were similar among the groups. The 2-year results confirm the conclusion reached after 1 year that once-weekly alendronate is therapeutically equivalent to daily dosing, providing patients with a more convenient dosing option that may potentially enhance adherence to therapy.