John Robbins, MD
Is raloxifene better than placebo for preventing bone mineral density (BMD) loss in postmenopausal women using long-term glucocorticoids?
Randomized placebo-controlled trial (RCT). ClinicalTrials.gov NCT00371956.
Unclear allocation concealment.*
Blinded (patients, clinicians, and outcome assessors).*
Outpatient rheumatology clinics at 2 hospitals in Hong Kong, China.
114 adult women (mean age 55 y) who were postmenopausal for ≥ 12 months; used a stable dose of prednisone, ≤ 10 mg/d or equivalent, for ≥ 6 months to treat rheumatic disease; and were expected to need corticosteroids throughout the study. Exclusion criteria included hypercoagulability risk factors (e.g., positive antiphospholipid antibodies); bone disorders (e.g., osteomalacia, renal osteodystrophy, and hyperparathrydoidism); undiagnosed uterine bleeding; serum creatinine level ≥ 200 µmol/L; history of thromboembolism, allergic reactions, or intolerance to selective estrogen receptor modulators (SERMs); and use of bisphosphonates, parathyroid hormones, SERMS, anticonvulsants, or anticytokine therapy in the past 6 months.
Raloxifene, 60 mg/d (n = 57), or placebo (n = 57). All patients received elemental calcium, 1000 mg/d, and calcitriol, 0.25 µg/d.
Lumbar spine and hip BMD. Other outcomes included new vertebral fractures and adverse events.
At 12 months, raloxifene increased lumbar spine and total hip BMD more than placebo (Table); groups did not differ for change in femoral neck BMD (data not reported) or new vertebral fractures (Table). The most frequent adverse events were leg cramps (7% vs 0%, P = 0.13), dyspepsia or heartburn (5% vs 9%, P = 0.71), dizziness or vertigo (5% vs 2%, P = 0.61), atypical chest pain (0% vs 7%, P = 0.13), and depression (0% vs 4%, P = 0.48). No arterial or venous thromboemboli were reported.
Raloxifene increased lumbar spine and total hip bone mineral density in postmenopausal women using long-term glucocorticoids for rheumatic disease.
Raloxifene vs placebo in postmenopausal women using long-term glucocorticoids†
†BMD = bone mineral density; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from event rates in article.
‡Adjusted for baseline BMD, age, body mass index, and cumulative prednisone dose during study.
Robbins J. Raloxifene increased bone mineral density in the spine and hips of postmenopausal women using long-term glucocorticoids. Ann Intern Med. ;155:JC3–4. doi: 10.7326/0003-4819-155-6-201109200-02004
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Published: Ann Intern Med. 2011;155(6):JC3-4.
Endocrine and Metabolism, Metabolic Bone Disorders.
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