Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: A randomized trial

D M Reid, R A Hughes, R F J M Laan, N A Sacco-Gibson, D H Wenderoth, S Adami, R A Eusebio, J P Devogelaer

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Abstract

Long-term use of high-dose corticosteroids often results in bone loss, which may lead to osteoporosis-related fractures. This was a multicenter, double-blind study in which 290 ambulatory men and women receiving high-dose oral corticosteroid therapy (prednisone greater than or equal to 7.5 mg/day or equivalent) for 6 or more months were randomized to receive placebo, risedronate 2.5 mg/day, or risedronate 5 mg/day for 12 months. All patients received calcium 1 g and vitamin D 400 IU daily. The primary endpoint was lumbar spine bone mineral density (BMD) at month 12, Additional measurements included BMD at the femoral neck and trochanter and the incidence of vertebral fractures, Overall, there were statistically significant treatment effects on BMD at 12 months at the lumbar spine (p < 0.001), femoral neck (p = 0.004), and trochanter (p = 0.010), Risedronate 5 mg increased BMD at 12 months by a mean (SEM) of 2.9% (0.49%) at the lumbar spine, 1.8% (0.46%) at the femoral neck, and 2.4% (0.54%) at the trochanter, whereas BMD was maintained only in the control group, Although not powered to show fracture efficacy, we observed a reduction in the incidence of vertebral fractures of 70% in the combined risedronate treatment groups, relative to placebo (p = 0.042), Risedronate was well tolerated, had a good safety profile, and was not associated with gastrointestinal adverse events. We conclude that risedronate increases BMD and potentially reduces the incidence of vertebral fractures in patients,vith corticosteroid-induced osteoporosis.

Original languageEnglish
Pages (from-to)1006-1013
Number of pages8
JournalJournal of Bone and Mineral Research
Volume15
Publication statusPublished - 2000

Keywords

  • osteoporosis
  • corticosteroids
  • bisphosphonate
  • risedronate
  • GLUCOCORTICOID-INDUCED OSTEOPOROSIS
  • BONE LOSS
  • PAGETS-DISEASE
  • RHEUMATOID-ARTHRITIS
  • FOLLOW-UP
  • PREVENTION
  • THERAPY
  • SPINE
  • STANDARDIZATION
  • MULTICENTER

Cite this

Reid, D. M., Hughes, R. A., Laan, R. F. J. M., Sacco-Gibson, N. A., Wenderoth, D. H., Adami, S., ... Devogelaer, J. P. (2000). Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: A randomized trial. Journal of Bone and Mineral Research, 15, 1006-1013.

Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: A randomized trial. / Reid, D M ; Hughes, R A ; Laan, R F J M ; Sacco-Gibson, N A ; Wenderoth, D H ; Adami, S ; Eusebio, R A ; Devogelaer, J P .

In: Journal of Bone and Mineral Research, Vol. 15, 2000, p. 1006-1013.

Research output: Contribution to journalArticle

Reid, DM, Hughes, RA, Laan, RFJM, Sacco-Gibson, NA, Wenderoth, DH, Adami, S, Eusebio, RA & Devogelaer, JP 2000, 'Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: A randomized trial', Journal of Bone and Mineral Research, vol. 15, pp. 1006-1013.
Reid, D M ; Hughes, R A ; Laan, R F J M ; Sacco-Gibson, N A ; Wenderoth, D H ; Adami, S ; Eusebio, R A ; Devogelaer, J P . / Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: A randomized trial. In: Journal of Bone and Mineral Research. 2000 ; Vol. 15. pp. 1006-1013.
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T1 - Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: A randomized trial

AU - Reid, D M

AU - Hughes, R A

AU - Laan, R F J M

AU - Sacco-Gibson, N A

AU - Wenderoth, D H

AU - Adami, S

AU - Eusebio, R A

AU - Devogelaer, J P

PY - 2000

Y1 - 2000

N2 - Long-term use of high-dose corticosteroids often results in bone loss, which may lead to osteoporosis-related fractures. This was a multicenter, double-blind study in which 290 ambulatory men and women receiving high-dose oral corticosteroid therapy (prednisone greater than or equal to 7.5 mg/day or equivalent) for 6 or more months were randomized to receive placebo, risedronate 2.5 mg/day, or risedronate 5 mg/day for 12 months. All patients received calcium 1 g and vitamin D 400 IU daily. The primary endpoint was lumbar spine bone mineral density (BMD) at month 12, Additional measurements included BMD at the femoral neck and trochanter and the incidence of vertebral fractures, Overall, there were statistically significant treatment effects on BMD at 12 months at the lumbar spine (p < 0.001), femoral neck (p = 0.004), and trochanter (p = 0.010), Risedronate 5 mg increased BMD at 12 months by a mean (SEM) of 2.9% (0.49%) at the lumbar spine, 1.8% (0.46%) at the femoral neck, and 2.4% (0.54%) at the trochanter, whereas BMD was maintained only in the control group, Although not powered to show fracture efficacy, we observed a reduction in the incidence of vertebral fractures of 70% in the combined risedronate treatment groups, relative to placebo (p = 0.042), Risedronate was well tolerated, had a good safety profile, and was not associated with gastrointestinal adverse events. We conclude that risedronate increases BMD and potentially reduces the incidence of vertebral fractures in patients,vith corticosteroid-induced osteoporosis.

AB - Long-term use of high-dose corticosteroids often results in bone loss, which may lead to osteoporosis-related fractures. This was a multicenter, double-blind study in which 290 ambulatory men and women receiving high-dose oral corticosteroid therapy (prednisone greater than or equal to 7.5 mg/day or equivalent) for 6 or more months were randomized to receive placebo, risedronate 2.5 mg/day, or risedronate 5 mg/day for 12 months. All patients received calcium 1 g and vitamin D 400 IU daily. The primary endpoint was lumbar spine bone mineral density (BMD) at month 12, Additional measurements included BMD at the femoral neck and trochanter and the incidence of vertebral fractures, Overall, there were statistically significant treatment effects on BMD at 12 months at the lumbar spine (p < 0.001), femoral neck (p = 0.004), and trochanter (p = 0.010), Risedronate 5 mg increased BMD at 12 months by a mean (SEM) of 2.9% (0.49%) at the lumbar spine, 1.8% (0.46%) at the femoral neck, and 2.4% (0.54%) at the trochanter, whereas BMD was maintained only in the control group, Although not powered to show fracture efficacy, we observed a reduction in the incidence of vertebral fractures of 70% in the combined risedronate treatment groups, relative to placebo (p = 0.042), Risedronate was well tolerated, had a good safety profile, and was not associated with gastrointestinal adverse events. We conclude that risedronate increases BMD and potentially reduces the incidence of vertebral fractures in patients,vith corticosteroid-induced osteoporosis.

KW - osteoporosis

KW - corticosteroids

KW - bisphosphonate

KW - risedronate

KW - GLUCOCORTICOID-INDUCED OSTEOPOROSIS

KW - BONE LOSS

KW - PAGETS-DISEASE

KW - RHEUMATOID-ARTHRITIS

KW - FOLLOW-UP

KW - PREVENTION

KW - THERAPY

KW - SPINE

KW - STANDARDIZATION

KW - MULTICENTER

M3 - Article

VL - 15

SP - 1006

EP - 1013

JO - Journal of Bone and Mineral Research

JF - Journal of Bone and Mineral Research

SN - 0884-0431

ER -