Short-term hemostatic safety of strontium ranelate treatment in elderly women with osteoporosis.
BACKGROUND
Strontium ranelate offers significant clinical benefits in terms of efficacy, tolerability, and ease of administration in the treatment of postmenopausal osteoporosis. However, there are some data revealing an association between strontium ranelate treatment and increased incidence of venous thromboembolism (VTE), suggesting possible adverse prothrombotic effects of the drug.


OBJECTIVE
To assess the effect of strontium ranelate treatment on primary hemostasis, secondary hemostasis, and the natural anticoagulant defense system, together with prothrombotic markers, in elderly women with osteoporosis.


METHODS
This study was designed in a prospective manner. Thirty-five elderly women diagnosed with osteoporosis were included. During a 2 month treatment period, participants received strontium ranelate 2 g. Platelet Function Analyzer-100 (PFA-100) in vitro bleeding time was performed to depict primary hemostasis. Secondary hemostatic parameters including prothrombin time, international normalized ratio, activated partial thromboplastin time, anti-cardiolipine immunoglobulin (Ig) M and IgG, antiphospholipid IgM and IgG, protein C, protein S, antithrombin III, lupus anticoagulant, fibrinogen, thrombin, activated protein C resistance, and plasma levels of d-dimer were assessed. These parameters were tested before and after 2 month treatment with strontium ranelate.


RESULTS
Mean +/- SD age of the patients was 72.82 +/- 5.69 years. After 60 days of treatment, there was no statistically significant prolongation in PFA-100 in vitro bleeding time and no statistically significant change in the critical hemostatic parameters in patients receiving strontium ranelate that led to discontinuation of the treatment. None of the subjects developed clinical VTE during the 2 month period of strontium ranelate treatment.


CONCLUSIONS
The hemostatic safety of strontium ranelate in the elderly population with osteoporosis was shown over 2 months of treatment; however, its long-term hemostatic safety should be evaluated further.
Halil
Meltem
M
Medical Faculty, Department of Internal Medicine, Division of Geriatric Medicine, Hacettepe University, Ankara, Turkey. meltemhalil@yahoo.com
Cankurtaran
Mustafa
M
Yavuz
Burcu Balam
BB
Ulger
Zekeriya
Z
Piskinpasa
Serhan
S
Gedik
Arzu
A
Haznedaroglu
Ibrahim Celalettin
IC
Kirazli
Serafettin
S
Ariogul
Servet
S
D000368:Aged; D001760:Bleeding Time; D005260:Female; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D010024:Osteoporosis / Q000097:blood / Q000188:drug therapy*; D011446:Prospective Studies; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors
D006490:Hemostatics; D009942:Organometallic Compounds; D013876:Thiophenes; C081587:strontium ranelate