Raloxifene plus ossein-hydroxyapatite compound versus raloxifene plus calcium carbonate to control bone loss in postmenopausal women: a randomized trial.

OBJECTIVE

To compare the efficacy and safety of adding ossein-hydroxyapatite compound (OHC) or calcium carbonate (CC) to raloxifene (RLX) therapy for controlling bone loss in postmenopausal women.

DESIGN

: Ninety postmenopausal women were assigned to treatment with RLX plus OHC (group 1, 48 women) or RLX plus CC (group 2, 42 women) for up to 3 years in an open-label, comparative study. Ultrasound measurement of amplitude-dependent speed of sound (ADSoS) was used to evaluate mean changes in bone mineral density. The primary endpoint was mean change of ADSoS from baseline. An intention to treat and per protocol analysis were carried out. Adverse effects were also recorded.

RESULTS

Over the study period, the mean ADSoS diminished in both groups even though the rate of reduction was higher in the RLX plus CC group, with a mean change in ADSoS score of -18.72 m/s from baseline to year 3 in the RLX plus OHC group and -63.64 m/s in the RLX+CC group (P = 0.006). Similar results were seen on T and Z scores. Adverse effects were infrequent and the number and type were similar between groups.

CONCLUSIONS

RLX plus OHC appears to be more effective in controlling bone loss than RLX plus CC for the control of bone loss in postmenopausal women.