14 Day Endoscopy Study Comparing Risedronate and Alendronate in Postmenopausal Women Stratified by Helicobacter pylori Status

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14 Day Endoscopy Study Comparing Risedronate and Alendronate in

Postmenopausal Women Stratified by Helicobacter pylori Status

ALAN B.R. THOMSON, JOHN K. MARSHALL, RICHARD H. HUNT, J. MARK PROVENZA,

FRANK L. LANZA, MARY G. ROYER, ZHENGQING LI, and MARION A. BLANK, for

the Risedronate Endoscopy Study Group

ABSTRACT.

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 ³ 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.

(J Rheumatol

2002;29:1965-74)