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J Endocrinol Invest. 2015 Feb;38(2):189-92. doi: 10.1007/s40618-014-0211-5. Epub 2014 Nov 21.

Gastrointestinal and renal side effects of bisphosphonates: differentiating between no proof of difference and proof of no difference.

Author information

1
HTA unit, Area Vasta Centro Toscana, Regional Health System, Via San Salvi 12, 50100, Florence, Italy.
2
HTA unit, Area Vasta Centro Toscana, Regional Health System, Via San Salvi 12, 50100, Florence, Italy. andrea.messori.it@gmail.com.

Abstract

BACKGROUND:

This study was aimed at comparing the safety of bisphosphonates in women with osteoporosis by application of equivalence testing.

METHODS:

Gastrointestinal and renal side effects were evaluated based on information published in randomized controlled trials.

RESULTS:

The data on gastrointestinal side effects (47 trials) indicated that alendronate, risedronate etidronate, and zolendronate have similar rates of the adverse effects; application of Bayesian network meta-analysis showed that equivalence was demonstrated according to margins around ±10%. The data on renal safety were more sparse and suffered from the use of different outcome measures; hence, a single trial could be evaluated. This trial showed a similar effect of alendronate and risedronate on renal function at 12 months; equivalence was based on differences between the two agents in renal function with margins of less than ±10.4 ml/min.

CONCLUSION:

Our study provided quantitative information to determine to what extent bisphosphonates can be considered equivalent in terms of gastrointestinal and renal side effects.

KEYWORDS:

Bisphosphonates; Equivalence; Osteoporosis; Safety

PMID:
25412945
DOI:
10.1007/s40618-014-0211-5
[Indexed for MEDLINE]

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