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  • Alendronate reduced days of bed rest and limited activity in postmenopausal women with osteoporosis and existing fractures

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Therapeutics
Alendronate reduced days of bed rest and limited activity in postmenopausal women with osteoporosis and existing fractures

https://doi.org/10.1136/ebm.5.4.119

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    (2000) Arch Intern Med 160, 77. Nevitt MC, Thompson DE, Black DM, et al.,. for the Fracture Intervention Trial Research Group. . Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures.. Jan 10;. :. -85..
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 QUESTION: In postmenopausal women with osteoporosis and ≥1 vertebral fracture, does alendronate reduce back pain and functional limitation caused by back pain?

    Design

    3 year randomised {allocation concealed*}†, blinded {patients, clinicians, and outcome assessors}†*, placebo controlled trial (Fracture-Intervention Trial [FIT]).

    Setting

    11 clinical centres in the US.

    Patients

    2027 women who were 55–81 years of age (mean age 71 y), had been postmenopausal for ≥2 years, had a femoral neck bone mineral density ≤0.68 g/cm2, and had ≥1 vertebral fracture. Follow up was 100%.

    Intervention

    Women were allocated to alendronate sodium, 5 mg/day for 2 years and 10 mg/day for the third year (n=1022), or placebo (n=1005).

    Main outcome measures

    Days of back pain and limited activity days related to back pain were assessed by questionnaire every …

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    Footnotes

    • Source of funding: Merck Research Laboratories.

    • For correspondence: Dr M C Nevitt, Epidemiology and Biostatistics, Prevention Sciences Group Coordinating Center–UCSF, 74 New Montgomery, Suite 600, San Francisco, CA 94105, USA. Fax +1 415 597 9213.

    • ↵* See glossary.

    • ↵† Black DM, Cummings SR, Karpf DB, et al, for the Fracture Intervention Trial Research Group. Lancet 1996;348:1535–41.