Ten Years' Experience with Alendronate for Osteoporosis in Postmenopausal Women
Open accessAbstract
BACKGROUND: Antiresorptive agents are widely used to treat osteoporosis. We report the results of a multinational randomized, double-blind study, in which postmenopausal women with osteoporosis were treated with alendronate for up to 10 years. METHODS: The initial three-year phase of the study compared three daily doses of alendronate with placebo. Women in the original placebo group received alendronate in years 4 and 5 and then were discharged. Women in the original active-treatment groups continued to receive alendronate during the initial extension (years 4 and 5). In two further extensions (years 6 and 7, and 8 through 10), women who had received 5 mg or 10 mg of alendronate daily continued on the same treatment. Women in the discontinuation group received 20 mg of alendronate daily for two years and 5 mg daily in years 3, 4, and 5, followed by five years of placebo. Randomized group assignments and blinding were maintained throughout the 10 years. We report results for the 247 women who participated in all four phases of the study. RESULTS: Treatment with 10 mg of alendronate daily for 10 years produced mean increases in bone mineral density of 13.7 percent at the lumbar spine (95 percent confidence interval, 12.0 to 15.5 percent), 10.3 percent at the trochanter (95 percent confidence interval, 8.1 to 12.4 percent), 5.4 percent at the femoral neck (95 percent confidence interval, 3.5 to 7.4 percent), and 6.7 percent at the total proximal femur (95 percent confidence interval, 4.4 to 9.1 percent) as compared with base-line values; smaller gains occurred in the group given 5 mg daily. The discontinuation of alendronate resulted in a gradual loss of effect, as measured by bone density and biochemical markers of bone remodeling. Safety data, including fractures and stature, did not suggest that prolonged treatment resulted in any loss of benefit. CONCLUSIONS: The therapeutic effects of alendronate were sustained, and the drug was well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects.
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There is abundant evidence that the elevated risk of fracture in patients with osteoporosis by BMD is reduced with pharmacotherapy.
“There is abundant evidence that the elevated risk of fracture in patients with osteoporosis by BMD is reduced with pharmacotherapy [52, 57, 59–70].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [61]
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- Authors
- Bone, H. G., Hosking, D., Devogelaer, J.-P., Tucci, J. R., Emkey, R. D., Tonino, R. P., Rodriguez-Portales, J. A., Downs, R. W., Gupta, J., Santora, A. C., & Liberman, U. A.
- Affiliations
- Nottingham City Hospital (GB)
- UCLouvain (BE)
- Roger Williams Medical Center (US)
- Virginia Commonwealth University (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Tel Aviv University (IL)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2004-03-18
- Volume
- 350
- Issue
- 12
- Pages
- 1189-1199
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2057332307
- Cited by
- 1,347
- References
- 49
- Citations by year
- 2026: 17 · 2025: 19 · 2024: 27 · 2023: 31 · 2022: 25 · 2021: 37 · 2020: 35 · 2019: 28 · 2018: 34 · 2017: 37 · 2016: 46 · 2015: 56 · 2014: 54 · 2013: 82 · 2012: 71
- FWCI
- 113.50
- Type
- journal article
- Language
- en
- Open access
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- VCU Scholars Compass (Virginia Commonwealth University) (submittedVersion)
- DIAL (Catholic University of Leuven) (submittedVersion)
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- alendronate, osteoporosis, postmenopausal women, bisphosphonates, antiresorptive therapy, long-term treatment, bone mineral density, lumbar spine, femoral neck, trochanter, fracture risk, drug safety
- MeSH terms
- Aged, Body Height, Double-Blind Method, Female, Humans, Middle Aged, Radiography, Time Factors, Bone Density, Osteoporosis, Postmenopausal, Spinal Fractures, Bone Remodeling, Alendronate, Fractures, Bone
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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