Osteoporosis International

, Volume 8, Issue 1, pp 4–12 | Cite as

Fluoride Salts are no Better at Preventing New Vertebral Fractures than Calcium-Vitamin D in Postmenopausal Osteoporosis: The FAVOStudy

  • P.J. Meunier
  • J.-L. Sebert
  • J.-Y. Reginster
  • D. Briancon
  • T. Appelboom
  • P. Netter
  • G. Loeb
  • A. Rouillon
  • S. Barry
  • J.-C. Evreux
  • B. Avouac
  • X. Marchandise
  • The FAVOStudy Group
Original Article

Abstract.

Although fluoride salts have been shown to be capable of linearly increasing spinal bone mineral density (BMD) in postmenopausal osteoporosis, the effects of this gain in density on the vertebral fracture rate remain controversial. We conducted a 2-year multicenter, prospective, randomized, double-masked clinical trial in 354 osteoporotic women with vertebral fractures (mean age 65.7 years). They received either fluoride (208 patients), given as sodium fluoride (50 mg/day) or as monofluorophosphate (200 mg/day or 150 mg/day), or a placebo (146 patients). All patients received daily supplements of 1 g of calcium (Ca) and 800 IU of vitamin D2 (D). A 1-year open follow-up on Ca-D was obtained in 124 patients. After 2 years the fluoride group and the Ca-D group had increased their lumbar BMD by 10.8% and 2.4% respectively (p = 0.0001). However, the rate of patients with at least one new vertebral fracture, defined by semiquantitative assessment and evaluable on an intention-to-treat basis in 89% of patients, was similar in the fluoride groups and the Ca-D group. No difference between the three fluoride regimens was found. The percentage of patients with nonvertebral fractures was not different in the fluoride and Ca-D groups (1.9% and 1.4% respectively for hip fractures). A lower limb pain syndrome occurred more frequently in the fluoride groups. In the 124 patients followed for 1 year after cessation of fluoride therapy, the percentage of patients with at least one new vertebral fracture after 36 months was identical to the percentages in the previous fluoride group and the Ca-D group. We conclude that flouride-Ca-D regimen was no more effective that Ca-D supplements for the prevention of new vertebral fractures in women with postmenopausal osteoporosis.

Key words: Caldium ; Monofluorophosphate; Postmenopausal osteoporosis; Sodium fluoride; Vertebral fracture; Vitamin D 

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Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 1998

Authors and Affiliations

  • P.J. Meunier
    • 1
  • J.-L. Sebert
    • 2
  • J.-Y. Reginster
    • 3
  • D. Briancon
    • 4
  • T. Appelboom
    • 5
  • P. Netter
    • 6
  • G. Loeb
    • 7
  • A. Rouillon
    • 8
  • S. Barry
    • 9
  • J.-C. Evreux
    • 10
  • B. Avouac
    • 11
  • X. Marchandise
    • 12
  • The FAVOStudy Group
  1. 1.Department of Rheumatology and Bone Disease, Edouard Herriot Hospital, Lyon, FranceFR
  2. 2.Department of Rheumatology, Hôpital Nord, Amiens, FranceFR
  3. 3.Bone and Cartilage Metabolism Unit and Department of Epidemiology and Public Health, University of Liège, BelgiumBE
  4. 4.Reine Hortense Hospital, Aix-les-Bains, FranceFR
  5. 5.Division of Rheumatology, Erasmus University Hospital, Brussels, BelgiumBE
  6. 6.Department of Pharmacology and URA CNRS 1288, Vandoeuvre-les-Nancy, FranceFR
  7. 7.Yamanouchi Pharma, Charenton-le-Pont, FranceFR
  8. 8.Merck-Clevenot Laboratories, Nogent sur Marne, FranceFR
  9. 9.RCTs, Lyon, France;FR
  10. 10.Centre Régional de Pharmacovigilance, Edouard Herriot Hospital, Lyon, FranceFR
  11. 11.Department of Rheumatology, Henri Mondor Hospital, Créteil, FranceGB
  12. 12.Nuclear Medicine Department, Roger Salengro Hospital, Lille, FranceFR

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