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Randomized Controlled Trial
. 2008 Feb;19(2):405-12.
doi: 10.1681/ASN.2006101089. Epub 2008 Jan 16.

Effects of sevelamer hydrochloride and calcium carbonate on renal osteodystrophy in hemodialysis patients

Aníbal Ferreira  1 , João Miguel Frazão, Marie-Claude Monier-Faugere, Célia Gil, José Galvao, Carlos Oliveira, Jorge Baldaia, Ilidio Rodrigues, Carla Santos, Silvia Ribeiro, Regula Mueller Hoenger, Ajay Duggal, Hartmut H Malluche; Sevelamer Study Group
Affiliations
Randomized Controlled Trial

Effects of sevelamer hydrochloride and calcium carbonate on renal osteodystrophy in hemodialysis patients

Aníbal Ferreira et al. J Am Soc Nephrol. 2008 Feb.

Abstract

Disturbances in mineral metabolism play a central role in the development of renal bone disease. In a 54-wk, randomized, open-label study, 119 hemodialysis patients were enrolled to compare the effects of sevelamer hydrochloride and calcium carbonate on bone. Biopsy-proven adynamic bone disease was the most frequent bone abnormality at baseline (59%). Serum phosphorus, calcium, and intact parathyroid hormone were well controlled in both groups, although calcium was consistently lower and intact parathyroid hormone higher among patients who were randomly assigned to sevelamer. Compared with baseline values, there were no changes in mineralization lag time or measures of bone turnover (e.g., activation frequency) after 1 yr in either group. Osteoid thickness significantly increased in both groups, but there was no significant difference between them. Bone formation rate per bone surface, however, significantly increased from baseline only in the sevelamer group (P = 0.019). In addition, of those with abnormal microarchitecture at baseline (i.e., trabecular separation), seven of 10 in the sevelamer group normalized after 1 yr compared with zero of three in the calcium group. In summary, sevelamer resulted in no statistically significant changes in bone turnover or mineralization compared with calcium carbonate, but bone formation increased and trabecular architecture improved with sevelamer. Further studies are required to assess whether these changes affect clinical outcomes, such as rates of fracture.

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Figures

Figure 1.
Figure 1.
Disposition of patients. The intention-to-treat (ITT) population was defined as all patients who were randomly assigned, received one or more doses of study medication, and had a second bone biopsy. One patient in the sevelamer group completed treatment but did not have a second bone biopsy and so was excluded from the ITT analysis. Two patients in the calcium group withdrew from the study early but received one or more doses of study medication and had a second bone biopsy and so were included in the ITT analysis.
Figure 2.
Figure 2.
Serum phosphorus (A), serum calcium (B), and serum iPTH (C) during 1 yr of treatment with sevelamer or calcium.
Figure 3.
Figure 3.
Changes in types of bone disease (based on qualitative evaluation of bone). OM, osteomalacia.
See this image and copyright information in PMC

References

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