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Risedronate therapy prevents corticosteroid-induced bone loss : A twelve-month, multicenter, randomized, double-blind, placebo-controlled, parallel-group study
- Source :
- Arthritis & Rheumatism. 42:2309-2318
- Publication Year :
- 1999
- Publisher :
- Wiley, 1999.
-
Abstract
- Objective Risedronate, a new pyridinyl bisphosphonate, is a potent antiresorptive bone agent. This study examines the safety and efficacy of daily, oral risedronate therapy for the prevention of corticosteroid-induced bone loss. Methods This multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted in 224 men and women who were initiating long-term corticosteroid treatment. Patients received either risedronate (2.5 mg or 5 mg) or placebo daily for 12 months. Each patient also received 500 mg of elemental calcium daily. The primary outcome measure was the percentage of change in lumbar spine bone mineral density (BMD). Secondary measures included proximal femur BMD and incidence of vertebral fractures. Results After 12 months, the lumbar spine BMD (mean ± SEM) did not change significantly compared with baseline in the 5-mg (0.6 ± 0.5%) or the 2.5-mg (−0.1 ± 0.7%) risedronate groups, while it decreased in the placebo group (−2.8 ± 0.5%; P < 0.05). The mean differences in BMD between the 5-mg risedronate and the placebo groups were 3.8 ± 0.8% at the lumbar spine (P < 0.001), 4.1 ± 1.0% at the femoral neck (P < 0.001), and 4.6 ± 0.8% at the femoral trochanter (P < 0.001). A trend toward a decrease in the incidence of vertebral fracture was observed in the 5-mg risedronate group compared with the placebo group (5.7% versus 17.3%; P = 0.072). Risedronate was well tolerated, and the incidence of upper gastrointestinal adverse events was comparable among the 3 groups. Conclusion Risedronate therapy prevents bone loss in patients initiating long-term corticosteroid treatment.
- Subjects :
- Bone mineral
medicine.medical_specialty
Trochanter
Bone disease
business.industry
medicine.medical_treatment
Immunology
Urology
Bisphosphonate
Placebo
medicine.disease
Surgery
Osteopenia
medicine.anatomical_structure
Rheumatology
Risedronic acid
medicine
Immunology and Allergy
Pharmacology (medical)
business
medicine.drug
Femoral neck
Subjects
Details
- ISSN :
- 15290131 and 00043591
- Volume :
- 42
- Database :
- OpenAIRE
- Journal :
- Arthritis & Rheumatism
- Accession number :
- edsair.doi...........b0bde888a3556b6c60affa33ea6719bf