Once-Weekly Oral Alendronate 70 mg in Patients with Glucocorticoid-Induced Bone Loss: A 12-Month Randomized, Placebo-Controlled Clinical Trial
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OBJECTIVE: Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy. METHODS: We conducted a 12-month, multicenter, randomized, double-blind, placebo-controlled trial with 114 and 59 patients in the treatment and placebo arms, respectively. Participants were stratified according to the duration of prior oral glucocorticoid therapy at randomization. Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D. Clinical evaluations were performed at baseline, 3, 6, 9, and 12 months. RESULTS: At 12 months, there was a significant mean percentage increase from baseline in the ALN OW group for lumbar spine (2.45%), trochanter (1.27%), total hip (0.75%), and total body (1.70%) bone mineral density (BMD). Comparing ALN OW versus placebo at 12 months, a significant treatment difference for the mean percentage change from baseline was observed for lumbar spine (treatment difference of 2.92%; p </= 0.001), trochanter (treatment difference 1.66%; p = 0.007), and total hip (treatment difference 1.19; p = 0.008) BMD. Biochemical markers of bone remodeling also showed significant mean percentage decreases from baseline. CONCLUSION: Over 12 months ALN OW significantly increased lumbar spine, trochanter, total hip, and total body BMD compared with baseline among patients taking glucocorticoid therapy. A significant treatment difference versus placebo was observed at 12 months for the mean percentage change from baseline for lumbar spine, trochanter, and total hip.
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In clinical practice, both bisphosphonates and PTH increase spine BMD to a greater extent than hip BMD.
“In clinical practice, both bisphosphonates and PTH increase the spine BMD to a greater extent than the hip BMD [12, 14, 47, 50-53].”
From Prevention of glucocorticoid induced bone changes with beta-ecdysone (2015) · cites this paper as [51]
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- Authors
- STOCH, S. A., SAAG, K. G., GREENWALD, M., SEBBA, A. I., COHEN, S., VERBRUGGEN, N., GIEZEK, H., WEST, J., & SCHNITZER, T. J.
- Affiliations
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Metroplex Clinical Research Center (US)
- ORCID
- Venue
- The Journal of Rheumatology
- Publisher
- The Journal of Rheumatology
- Published
- 2009-06-01
- Volume
- 36
- Issue
- 8
- Pages
- 1705-1714
- ISSN
- 0315-162X (ISSN-L)
- 1499-2752
- OpenAlex
- W2115647238
- Cited by
- 100
- References
- 47
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 3 · 2023: 10 · 2022: 6 · 2021: 8 · 2020: 5 · 2019: 7 · 2018: 6 · 2017: 4 · 2016: 7 · 2015: 3 · 2014: 5 · 2013: 8 · 2012: 7
- FWCI
- 7.69
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Rheumatology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Amgen
- Eli Lilly and Company
- Sanofi
- Procter and Gamble
- Biogen
- IC Design Education Center
- Genentech
- 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
- glucocorticoid-induced osteoporosis, alendronate, bone mineral density, bone turnover markers, calcium and vitamin D supplementation, lumbar spine, hip
- MeSH terms
- Administration, Oral, Adult, Aged, Calcium, Drug Therapy, Combination, Female, Glucocorticoids, Hip Joint, Humans, Lumbar Vertebrae, Male, Middle Aged, Osteoporosis, Placebos, Rheumatic Diseases, Vitamin D, Biomarkers, Bone Density, Alendronate, Bone Density Conservation Agents
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