Effects of zoledronic acid versus placebo on bone mineral density and bone texture analysis assessed by the trabecular bone score in premenopausal women with breast cancer treatment-induced bone loss: results of the ProBONE II substudy.
Changes in bone mineral density (BMD) and trabecular bone score (TBS) were assessed in 70 patients who received either zoledronate (ZOL) (n = 34) or placebo (n = 36) for 2 years. In premenopausal women with breast cancer treatment-induced bone loss, 24 months of intravenous ZOL treatment significantly increased the lumbar spine BMD and the TBS.


BACKGROUND
The aim of this study was to compare the effects of 4 mg intravenous zoledronate (ZOL) versus placebo (PLB), every 3 months, on the lumbar spine (LS) bone mineral density (BMD) and the trabecular bone score (TBS) in premenopausal women with breast cancer (BC) treatment-induced bone loss. The TBS is a gray-level texture measurement which is related to the bone microarchitecture and considered to be independent of the BMD.


METHODS
Changes in BMD and TBS were assessed in 70 patients who were recruited in the double-blind, placebo-controlled ProBONE-II trial and randomized to receive either ZOL (n = 34) or PLB (n = 36) for 2 years. The changes were assessed at baseline and at 12 and 24 months after treatment initiation.


RESULTS
Patients receiving ZOL showed a mean increase in LS BMD from the baseline to 12 (2.17%) and 24 months (3.14%) of treatment and a mean increase in the TBS of 2.41 and 0.75%, respectively. Conversely, patients receiving PLB showed a mean decrease in the LS BMD from the baseline to 12 (-5.02%) and 24 (-6.43%) months and a mean decrease of -0.52 and -2.16% in the TBS, respectively. Changes in the BMD and the TBS from the baseline to 12 and 24 months were all significantly different for ZOL compared to PLB (p < 0.005). Furthermore, BMD and TBS showed a moderate correlation ranging from 0.28 (p = 0.087) to 0.47 (p = 0.003).


CONCLUSIONS
In premenopausal women with BC, 24 months of intravenous ZOL treatment significantly increased the LS BMD as well as the TBS.
Department of Obstetrics and Gynecology, Philipps University of Marburg, Baldingerstrasse, 35043, Marburg, Germany, kalder@med.uni-marburg.de.
M
M
Kalder
I
I
Kyvernitakis
U S
US
Albert
M
M
Baier-Ebert
P
P
Hadji
D015502:Absorptiometry, Photon / Q000379:methods; D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D004164:Diphosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D007275:Injections, Intravenous; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000188:drug therapy* / Q000503:physiopathology; D017697:Premenopause / Q000502:physiology; D000077211:Zoledronic Acid
D000970:Antineoplastic Agents; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid