Alendronate for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis
Open accessAbstract
BACKGROUND: Osteoporosis is a common complication of long-term glucocorticoid therapy for which there is no well-proved preventive or restorative treatment. METHODS: We carried out two 48-week, randomized, placebo-controlled studies of two doses of alendronate in 477 men and women, 17 to 83 years of age, who were receiving glucocorticoid therapy. The primary end point was the difference in the mean percent change in lumbar-spine bone density from base line to week 48 between the groups. Secondary outcomes included changes in bone density of the hip, biochemical markers of bone turnover, and the incidence of new vertebral fractures. RESULTS: The mean (+/-SE) bone density of the lumbar spine increased by 2.1+/-0.3 percent and 2.9+/-0.3 percent, respectively, in the groups that received 5 and 10 mg of alendronate per day (P<0.001) and decreased by 0.4+/-0.3 percent in the placebo group. The femoral-neck bone density increased by 1.2+/-0.4 percent and 1.0+/-0.4 percent in the respective alendronate groups (P<0.01) and decreased by 1.2+/-0.4 percent in the placebo group (P<0.01). The bone density of the trochanter and total body also increased significantly in the patients treated with alendronate. There were proportionally fewer new vertebral fractures in the alendronate groups (overall incidence, 2.3 percent) than in the placebo group (3.7 percent) (relative risk, 0.6; 95 percent confidence interval, 0.1 to 4.4). Markers of bone turnover decreased significantly in the alendronate groups (P<0.001). There were no differences in serious adverse effects among the three groups, but there was a small increase in nonserious upper gastrointestinal effects in the group receiving 10 mg of alendronate. CONCLUSIONS: Alendronate increases bone density in patients receiving glucocorticoid therapy.
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Alendronate is approved by the FDA for treatment to increase bone mass in men with osteoporosis and for the treatment of osteoporosis in men and women taking glucocorticoids.
“Alendronate is also approved for treatment to increase bone mass in men with osteoporosis and for the treatment of osteoporosis in men and women taking glucocorticoids [73].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [73]
The Abstract reports increased bone density in men and women receiving glucocorticoids, and the Discussion says the findings support treating glucocorticoid-induced osteoporosis. Our copy does not establish FDA approval or address treatment to increase bone mass in men with osteoporosis outside the glucocorticoid setting (searched: FDA approval and approval for men with osteoporosis). (LLM, conf=0.84)
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Self-citation
- Authors
- Saag, K. G., Emkey, R., Schnitzer, T. J., Brown, J. P., Hawkins, F., Goemaere, S., Thamsborg, G., Liberman, U. A., Delmas, P. D., Malice, M.-P., Czachur, M., Daifotis, A. G., Lane, N., Correa-Rotter, R., Yanover, M., Westhovens, R., Epstein, S., Adachi, J. D., Poubelle, P., Melo-Gomes, J., & Rodriguez-Portales, J. A.
- Affiliations
- University of Iowa (US)
- Northwestern University (US)
- Centre hospitalier universitaire de Québec (CA)
- Hospital Universitario 12 De Octubre (ES)
- Ghent University Hospital (BE)
- Hôpital Edouard Herriot (FR)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (MX)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1998-07-30
- Volume
- 339
- Issue
- 5
- Pages
- 292-299
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2314674563
- Cited by
- 1,258
- References
- 32
- Citations by year
- 2026: 11 · 2025: 13 · 2024: 17 · 2023: 17 · 2022: 17 · 2021: 30 · 2020: 30 · 2019: 26 · 2018: 24 · 2017: 25 · 2016: 23 · 2015: 27 · 2014: 29 · 2013: 47 · 2012: 31
- FWCI
- 81.52
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Funders
- National Center for Research Resources (RR 00059, M01RR000059)
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- alendronate, glucocorticoid-induced osteoporosis, glucocorticoid therapy, bone mineral density, lumbar spine, femoral neck, vertebral fractures, bone turnover markers, bisphosphonates, osteoporosis prevention, osteoporosis treatment
- MeSH terms
- Adolescent, Aged, Aged, 80 and over, Double-Blind Method, Female, Glucocorticoids, Humans, Male, Middle Aged, Osteoporosis, Prednisone, Risk Factors, Bone Density, Spinal Fractures, Alendronate
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