Original Article

Osteoporosis International

, Volume 9, Issue 5, pp 461-468

First online:

Multinational, Placebo-Controlled, Randomized Trial of the Effects of Alendronate on Bone Density and Fracture Risk in Postmenopausal Women with Low Bone Mass: Results of the FOSIT Study

  • H. A. P. PolsAffiliated withErasmus University Medical School, Rotterdam, The Netherlands
  • , D. FelsenbergAffiliated withFree University of Berlin, Berlin, Germany
  • , D. A. HanleyAffiliated withUniversity of Calgary, Calgary, Alberta, Canada
  • , J. ŠtepánAffiliated withCharles University, Prague, Czech Republic
  • , M. Muñoz-TorresAffiliated withHospital Clinico San Cecilio, Granada, Spain
  • , T. J. WilkinAffiliated withFreedom Fields Hospital, Plymouth, Devon, UK
  • , G. Qin-shengAffiliated withPeking Union Medical College Hospital, Beijing, People’s Republic of China
  • , A. M. GalichAffiliated withHospital Italiano de Buenos Aires, Buenos Aires, Argentina
  • , K. VandormaelAffiliated withMerck Research Laboratories, Brussels, Belgium
    • , A. J. YatesAffiliated withErasmus University Medical School, Rotterdam, The NetherlandsMerck Research Laboratories, Rahway, New Jersey, USA
    • , B. StychAffiliated withErasmus University Medical School, Rotterdam, The NetherlandsMerck & Co., Inc., Whitehouse Station, New Jersey, USA
    • , for the Fosamax® International Trial Study Group

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This randomized, double-masked, placebo-controlled trial evaluated the safety, tolerability and effects on bone mineral density (BMD) of alendronate in a large, multinational population of postmenopausal women with low bone mass. At 153 centers in 34 countries, 1908 otherwise healthy, postmenopausal women with lumbar spine BMD 2 standard deviations or more below the premenopausal adult mean were randomly assigned to receive oral alendronate 10 mg (n = 950) or placebo (n = 958) once daily for 1 year. All patients received 500 mg elemental calcium daily. Baseline characteristics of patients in the two treatment groups were similar. At 12 months, mean increases in BMD were significantly (p≤0.001) greater in the alendronate than the placebo group by 4.9% (95% confidence interval 4.6% to 5.2%) at the lumbar spine, 2.4% (2.0% to 2.8%) at the femoral neck, 3.6% (3.2% to 4.1%) at the trochanter and 3.0% (2.6% to 3.4%) for the total hip. The incidence of nonvertebral fractures was significantly lower in the alendronate than the placebo group (19 vs 37 patients with fractures), representing a 47% risk reduction for nonvertebral fracture for alendronate-treated patients (95% confidence interval 10% to 70%; p= 0.021). Incidences of adverse events, including upper gastrointestinal adverse events, were similar in the two groups. Therefore, for postmenopausal women with low bone mass, alendronate is well tolerated and produces significant, progressive increases in BMD at the lumbar spine and hip in addition to significant reduction in the risk of nonvertebral fracture.

Key words:Alendronate – bisphosphonate – Bone mineral density – Fractures – Postmenopausal osteoporosisRID=""ID="" <E5>Correspondence and offprint requests to:</E5> Huibert A. P. Pols, MD,&thinsp;PhD, Department of Internal Medicine III, Erasmus University Medical School, PO Box 1738, 3000 DR Rotterdam, The Netherlands. Tel: &plus;31 10 4635956. Fax: &plus;31 10 4633268. e-mail: pols@epib.fgg.eur.nl.RID=""ID=""Fosamax<SUP>&reg;</SUP> is a registered trademark of Merck &amp; Co., Inc., Whitehouse Station, NJ, USA.