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.


METHODS
: 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.
Pelayo
Irene
I
Department of Gynecology and Obstetrics, Hospital Ramón y Cajal, Madrid, Spain. ipelayod@yahoo.com
Haya
Javier
J
De la Cruz
Juan J
JJ
Seco
Carlos
C
Bugella
Juan I
JI
Diaz
Jose L
JL
Bajo
Jose M
JM
Repolles
Manuel
M
D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D002119:Calcium Carbonate / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D017886:Durapatite / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D017060:Patient Satisfaction; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*
D050071:Bone Density Conservation Agents; D020849:Raloxifene Hydrochloride; D017886:Durapatite; D002119:Calcium Carbonate