Srpski arhiv za celokupno lekarstvo 2012 Volume 140, Issue 11-12, Pages: 722-727
https://doi.org/10.2298/SARH1212722S
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Efficacy and safety of once-monthly ibandronate treatment in patients with low bone mineral density – ESTHER study: 24 months of follow-up
Simić-Pašalić Katarina (Institut za reumatologiju, Beograd)
ESTHER Study Group
Introduction. Osteoporosis is a major health and economic problem worldwide.
The use of new drugs, such as ibandronate, is aimed at improving treatment of
osteoporosis and currently poor compliance with BP therapy. Objective. To
investigate efficacy and safety of ibandronate applied monthly, orally, in
women with low bone mineral density (BMD). Methods. The prospective study was
conducted in 34 centers in Serbia and included 77 women treated for 24 months
with monthly ibandronate. The efficacy of treatment was assessed by change in
bone mass values obtained by BMD measurement at the end of 24 months
follow-up versus baseline and 12-months follow-up values. Compliance and
safety, i.e. adverse effects (AE) were recorded. Results. Participants were
postmenopausal (96%), osteoporotic (79.7%) females, diagnosed by lumbar spine
DXA measurement (81%), with history of prior BP therapy in 33.8% women. The
physical activity level significantly increased to the substantial level of
activity (5.2% vs. 21.3%, p=0.003) during the study. After 12 and 24 months
of treatment, BMD values significantly increased (p=0.002 and p<0.001). BP
experienced patients improved more than BP naïve patients at both time points
(p=0.012 and p=0.027, respectively). During the second 12 months of treatment
the adherence was 96%; AE were recorded as mild gastrointestinal disturbances
in 3.9%. Conclusion. Treatment by using ibandronate once monthly for 24
months was generally well tolerated and led to a significant increase in BMD
in women with low BMD.
Keywords: osteoporosis, bone mineral density, bisphosphonates, ibandronat
Acknowledgement. We extend our thanks to
all members of ESTHER Study Group: Kovačev B, Dimić A, Branković S,
Andjelković Z, Palić Obradović D, Erdeljan B, Vukašinović D, Buković S,
Janković T, Kiš M, Bubanja D, Mladenović G, Prodanović N, Džambazoski M,
Ristić N, Ranković O, Jovičević R, Lević Z, Ristanović V, Urošević Lj, Djurić
M, Mijailović M, Filipov R, Živković S, Kević S, Petrović V, Vojnović Ćulafić
V, Grujić Z, Nestorović V, Jonić B, Toljić Šulubić D, Božović Jelić J,
Mrvošević Marojević Lj, Drezgić M, Jovanović S.