10391
document
14 day endoscopy study comparing risedronate and alendronate in postmenopausal women stratified by Helicobacter pylori status . OBJECTIVE Bisphosphonates are effective treatment for osteoporosis but have been associated with gastrointestinal ( GI ) mucosal injury . This study compared the incidence of gastric ulcers after treatment with risedronate , a pyridinyl bisphosphonate , or alendronate , a primary amino bisphosphonate , in healthy postmenopausal women stratified by Helicobacter pylori status . METHODS Subjects were randomized to receive risedronate 5 mg ( n = 318 ) or alendronate 10 mg ( n = 317 ) daily for 14 days . Endoscopy and evaluator-blind assessments of the esophageal , gastric , and duodenal mucosa were performed at baseline and on Days 8 and 15 . RESULTS Overall , gastric ulcers > or = 3 mm were observed in 18 ( 6.0 % ) of 300 evaluable subjects in the risedronate group and 36 ( 12.1 % ) of 297 in the alendronate group during treatment ( p = 0.013 ) . On Day 8 , the incidences of gastric ulcers in the risedronate and alendronate groups were 3.6 % and 6.6 % , respectively ( p = 0.133 ) , and on Day 15 , they were 3.3 % and 8.7 % ( p = 0.008 ) . The incidence of gastric ulcers was not affected by H. pylori status . Mean gastric endoscopy scores at Days 8 and 15 were significantly lower in the risedronate group than in the alendronate group ( p < 0.001 ) . Mean esophageal and duodenal endoscopy scores were similar in the 2 groups at Days 8 and 15 . When the treatment groups were combined , gastric endoscopy scores were significantly higher among H. pylori negative than H. pylori positive subjects at Days 8 and 15 ( p < 0.05 ) . Upper GI adverse events were reported by 18 ( 5.7 % ) subjects in the risedronate group ( 19 events ) and 28 ( 8.8 % ) subjects in the alendronate group ( 32 events ) . Symptoms did not predict the presence of mucosal damage . CONCLUSION Risedronate was associated with a significantly lower incidence of gastric ulcers than alendronate . H. pylori infection did not increase the incidence of bisphosphonate related gastric ulcers . The findings from this 14 day study in healthy volunteers support the hypothesis that bisphosphonates may differ from one another in their potential to produce upper GI mucosal damage .
10392
Intervention_Pharmacological
risedronate
10393
Intervention_Pharmacological
alendronate
10394
Intervention_Pharmacological
Bisphosphonates
10395
Intervention_Pharmacological
risedronate
10396
Intervention_Pharmacological
pyridinyl bisphosphonate
10397
Intervention_Pharmacological
alendronate
10398
Intervention_Pharmacological
primary amino bisphosphonate
10399
Intervention_Pharmacological
risedronate
10400
Intervention_Pharmacological
alendronate
10401
Intervention_Surgical
Endoscopy
10402
Intervention_Pharmacological
risedronate
10403
Intervention_Pharmacological
risedronate
10404
Intervention_Pharmacological
alendronate
10405
Intervention_Pharmacological
risedronate
10406
Intervention_Pharmacological
alendronate
10407
Intervention_Pharmacological
risedronate
10408
Intervention_Pharmacological
alendronate
10409
Intervention_Pharmacological
Risedronate
10410
Intervention_Pharmacological
alendronate
10411
Outcome_Physical
gastric ulcers
10412
Outcome_Physical
incidences of gastric ulcers
10413
Outcome_Physical
incidence of gastric ulcers
10414
Outcome_Other
Mean gastric endoscopy scores
10415
Outcome_Other
Mean esophageal and duodenal endoscopy scores
10416
Outcome_Other
gastric endoscopy scores
10417
Outcome_Adverse-effects
Upper GI adverse events
10418
Participant_Condition
postmenopausal
10419
Participant_Sex
women
10420
Participant_Condition
Helicobacter pylori
10421
Participant_Condition
healthy postmenopausal
10422
Participant_Sex
women
10423
Participant_Condition
Helicobacter pylori