Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate
Abstract
Background We studied 265 men (mean age 56.4 years; range 18-83 years), among patients enrolled in two arms of a double-blind, 1-year study comparing the effects of zoledronic acid (ZOL) with risedronate (RIS) in patients either commencing (prednisolone 7.5 mg/day or equivalent) (prevention arm, n=88) or continuing glucocorticoid therapy (treatment arm, n=177).Methods Patients received either a single ZOL 5 mg infusion or RIS 5 mg oral daily at randomization, along with calcium (1000 mg) and vitamin D (400-1200 IU). Primary endpoint: difference in percentage change from baseline in bone mineral density (BMD) at the lumbar spine (LS) at 12 months. Secondary endpoints: percentage changes in BMD at total hip (TH) and femoral neck (FN), relative changes in bone turnover markers (β-CTx and P1NP), and overall safety.Findings In the treatment subpopulation, ZOL increased LS BMD by 4.7% vs. 3.3% for RIS and at TH the percentage changes were 1.8% vs. 0.2%, respectively. In the prevention subpopulation, bone loss was prevented by both treatments. At LS the percentage changes were 2.5% vs. -0.2% for ZOL vs. RIS and at TH the percentage changes were 1.1% vs. -0.4%, respectively. ZOL significantly increased lumbar spine BMD more than RIS at Month 12 in both the prevention population (p=0.0024) and the treatment subpopulation (p=0.0232) in men. In the treatment subpopulation, ZOL demonstrated a significantly greater reduction in serum β-CTx and P1NP relative to RIS at all time-points. In the prevention subpopulation, ZOL significantly reduced β-CTx at all time-points, and P1NP at Month 3 (p=0.0297) only. Both treatments were well tolerated in men, albeit with a higher incidence of influenza-like illness and pyrexia events post-infusion with ZOL.Interpretation Once-yearly ZOL preserves or increases BMD within 1 year to a greater extent than daily RIS in men receiving glucocorticoid therapy.
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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 [53]
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- Authors
- Sambrook, P. N., Roux, C., Devogelaer, J.-P., Saag, K., Lau, C.-S., Reginster, J.-Y., Bucci-Rechtweg, C., Su, G., & Reid, D. M.
- Affiliations
- The University of Sydney (AU)
- Université Paris Descartes (FR)
- UCLouvain (BE)
- University of Alabama at Birmingham (US)
- University of Dundee (GB)
- University of Liège (BE)
- University of Aberdeen (GB)
- Corresponding author
- Sambrook, Philip N.
- ORCID
- Venue
- Bone
- Publisher
- Elsevier BV
- Published
- 2012-01
- Volume
- 50
- Issue
- 1
- Pages
- 289-295
- ISSN
- 1873-2763 (ISSN-L)
- 8756-3282
- OpenAlex
- W1545053868
- Cited by
- 3
- References
- 40
- Citations by year
- 2020: 1 · 2014: 1 · 2012: 1
- FWCI
- 0.68
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Bone (publishedVersion)
- PubMed (publishedVersion)
- Digital Access to Libraries (submittedVersion)
- Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion)
- ORBi (University of Liège) (submittedVersion)
- Osteoporosis International
- Funders
- Novartis
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Bone Metabolism and Diseases
- Keywords
- glucocorticoid-induced osteoporosis, zoledronic acid, risedronate, bisphosphonates, men, bone mineral density, prednisolone, bone turnover markers, bone resorption, femoral neck, lumbar spine, total hip, drug safety, influenza-like illness, fever, calcium and vitamin D supplementation
- MeSH terms
- Risedronic Acid, Zoledronic Acid, Adolescent, Adult, Aged, Aged, 80 and over, Diphosphonates, Double-Blind Method, Femur Neck, Glucocorticoids, Hip Joint, Humans, Imidazoles, Lumbar Vertebrae, Male, Middle Aged, Osteoporosis, Etidronic Acid, Bone Density, Bone Density Conservation Agents, Young Adult
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