Osteoporosis International

, Volume 14, Issue 9, pp 741–749

Effect of raloxifene combined with monofluorophosphate as compared with monofluorophosphate alone in postmenopausal women with low bone mass: a randomized, controlled trial

  • Jean Yves Reginster
  • Dieter Felsenberg
  • Imre Pavo
  • Jan Stepan
  • Juraj Payer
  • Heinrich Resch
  • Claus C. Glüer
  • Dieter Mühlenbacher
  • Deborah Quail
  • Henry Schmitt
  • Thomas Nickelsen
Original Article

DOI: 10.1007/s00198-003-1432-1

Cite this article as:
Reginster, J.Y., Felsenberg, D., Pavo, I. et al. Osteoporos Int (2003) 14: 741. doi:10.1007/s00198-003-1432-1

Abstract

Raloxifene effectively reduces the incidence of vertebral fractures in patients with postmenopausal osteoporosis. Recent data suggest that low-dose monofluorophosphate (MFP) plus calcium reduces the vertebral fracture rate in postmenopausal women with moderate osteoporosis. The objective of this study was to evaluate the combination of raloxifene and MFP in the treatment of postmenopausal women with osteopenia, osteoporosis and severe osteoporosis. A total of 596 postmenopausal women with osteopenia, osteoporosis and severe osteoporosis (mean femoral neck T-score of –2.87 SD) were randomized to treatment with 60 mg/day raloxifene HCl and 20 mg/day fluoride ions (as MFP) or 20 mg/day fluoride and placebo for 18 months. All patients received calcium (1000 mg/day) and vitamin D (500 IU/day) supplements. Changes in bone mineral density (BMD), as primary endpoint, and the rate of osteoporotic fractures and biochemical markers, as secondary endpoints, were assessed. As compared with MFP, raloxifene plus MFP was associated with significantly greater mean increases in the BMD of the femoral neck (1.37% versus 0.33%; P=0.004), total hip (0.89% versus −0.42%; P<0.001) and lumbar spine (8.80% versus 5.47% P<0.001). In the raloxifene plus MFP group, 16 patients sustained 17 osteoporotic fractures, as compared with 22 patients sustaining 34 incident osteoporotic fractures in the MFP group (P=0.313). One patient in the raloxifene plus MFP group sustained multiple osteoporotic fractures, as compared with eight patients in the MFP group (P=0.020). MFP alone significantly increased the serum bone alkaline phosphatase (bone ALP) and the urinary C-terminal crosslinking telopeptide of type I collagene (U-CTX). The addition of raloxifene in the combination arm blunted the rise in bone ALP, which remained nevertheless significant, and abolished the increase in U-CTX. The combination of raloxifene with MFP was generally well tolerated. This study demonstrates that, in postmenopausal women with osteopenia, osteoporosis and severe osteoporosis, the combination therapy of raloxifene plus MFP favorably influences the BMD and the bone formation and resorption balance, and may reduce the risk of multiple osteoporotic fractures compared to MFP alone.

Keywords

Raloxifene Fluoride BMD Bone markers Fractures Osteoporosis 

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2003

Authors and Affiliations

  • Jean Yves Reginster
    • 1
    • 8
  • Dieter Felsenberg
    • 2
  • Imre Pavo
    • 3
  • Jan Stepan
    • 4
  • Juraj Payer
    • 5
  • Heinrich Resch
    • 6
  • Claus C. Glüer
    • 7
  • Dieter Mühlenbacher
    • 3
  • Deborah Quail
    • 3
  • Henry Schmitt
    • 3
  • Thomas Nickelsen
    • 3
  1. 1.Bone and Cartilage Metabolism Research UnitUniversity of LiegeLiegeBelgium
  2. 2.Centre of Muscle and Bone Research, University Hospital Benjamin FranklinFree University BerlinGermany
  3. 3.Lilly Research LaboratoriesEli Lilly and CompanyIndianapolisUSA
  4. 4.Department of Internal Medicine 3Charles University Faculty of MedicinePragueCzech Republic
  5. 5.First Clinic of Internal Medicine, Faculty of MedicineComenius UniversityBratislavaSlovakia
  6. 6.Department of Internal MedicineSt Vincent HospitalViennaAustria
  7. 7.Department of RadiologyUniversity HospitalKielGermany
  8. 8.WHO Collaborating Center for Public Health Aspects of Rheumatic DiseasesCHO Centre VilleLiegeBelgium

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