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document
Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis . Vertebral Efficacy with Risedronate Therapy ( VERT ) Study Group . The purpose of this randomized , double-masked , placebo-controlled study was to determine the efficacy and safety of risedronate in the prevention of vertebral fractures in postmenopausal women with established osteoporosis . The study was conducted at 80 study centers in Europe and Australia . Postmenopausal women ( n = 1226 ) with two or more prevalent vertebral fractures received risedronate 2.5 or 5 mg/day or placebo ; all subjects also received elemental calcium 1000 mg/day , and up to 500 IU/day vitamin D if baseline levels were low . The study duration was 3 years ; however , the 2.5 mg group was discontinued by protocol amendment after 2 years . Lateral spinal radiographs were taken annually for assessment of vertebral fractures , and bone mineral density was measured by dual-energy X-ray absorptiometry at 6-month intervals . Risedronate 5 mg reduced the risk of new vertebral fractures by 49 % over 3 years compared with control ( p < 0.001 ) . A significant reduction of 61 % was seen within the first year ( p = 0.001 ) . The fracture reduction with risedronate 2.5 mg was similar to that in the 5 mg group over 2 years . The risk of nonvertebral fractures was reduced by 33 % compared with control over 3 years ( p = 0.06 ) . Risedronate significantly increased bone mineral density at the spine and hip within 6 months . The adverse-event profile of risedronate , including gastrointestinal adverse events , was similar to that of control . Risedronate 5 mg provides effective and well-tolerated therapy for severe postmenopausal osteoporosis , reducing the incidence of vertebral fractures and improving bone density in women with established disease .
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Intervention_Pharmacological
risedronate
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Intervention_Pharmacological
risedronate
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Intervention_Control
placebo
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Intervention_Pharmacological
elemental calcium 1000 mg/day
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Intervention_Pharmacological
vitamin D
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Outcome_Physical
vertebral fractures
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Outcome_Other
efficacy and safety of risedronate
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Outcome_Physical
vertebral fractures
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Outcome_Physical
vertebral fractures
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Outcome_Physical
bone mineral density
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Outcome_Physical
vertebral fractures
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Outcome_Physical
fracture reduction
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Outcome_Physical
nonvertebral fractures
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Outcome_Physical
bone mineral density
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Outcome_Adverse-effects
gastrointestinal adverse events
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Participant_Sex
women
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Participant_Condition
postmenopausal osteoporosis
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Participant_Condition
postmenopausal
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Participant_Sex
women
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Participant_Condition
established osteoporosis
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Participant_Sex
women
2641
Participant_Sample-size
n = 1226
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Participant_Condition
with two or more prevalent vertebral fractures
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Participant_Condition
severe postmenopausal osteoporosis
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Participant_Sex
women
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Participant_Condition
with established disease