EFFEKTIVNOST', PERENOSIMOST'I KOMPLAENTNOST' ALENDRONATA NATRIYa(70 MG 1 RAZ V NEDELYu)PRI LEChENII POSTMENOPAUZAL'NOGO OSTEOPOROZA
Abstract
The aim of this study was to assess effectiveness ant tolerability of alendronate in women suffered of postmenopausal osteoporosis.
15 postmenopausal women with primary osteoporosis (age 61.0±4.8 (M±σ) years) was administered alendronate in dosage 70 mg weekly with calcium supplementation (1000 mg daily) for 12 months. Control group consisted of 19 women also suffered from postmenopausal osteoporosis (age 61.7±5.2 years) received only calcium salts for study period.
There was a significant increase vs baseline in BMD in lumbar spine (in 2.1% in 6 months and in 2.7% in 12 months), in femoral neck from (in 2.1% and 3.3% accordingly), in trochanter (in 5.5% and 6.3% accordingly) and in total proximal femur (in 2.9% and 1.9% accordingly) in treated patients. We also found in treated group a marked decrease in serum ionized calcium from 1.24±0.03 to 1.21±0.03 mmol/l in 6 months and to 1.2±0.04 mmol/l in 12 months (р<0.05 vs baseline), in alkaline phosphatase from 98.7±44.8 to 63.5±15.6 u/l in 6 months (р<0.05 vs baseline) and to 60.7±13.8 u/l in 12 months (р<0.05 vs baseline and p<0.0001 vs control), in osteocalcin from 28.0±8.7 to 23.4±10.4 ng/ml in 6 months and to 20.3±8.2 ng/ml (p<0.05 vs control), and in urinary calcium/creatinine excretion and daily calcium excretion. Back pain and quality of life significantly improved in treated group, and regimen of alendronate dosing was highly convenient in all patients' opinion. Tolerability of alendronate was satisfactory but 3 patients stopped the treatment due to gastrointestinal side effects.
Those results demonstrate that alendronate in dosage 70 mg weekly increases BMD, decreases serum and urinary calcium and bone turnover markers, improved back pain and quality of life and is at satisfactory tolerability in women with postmenopausal osteoporosis.
15 postmenopausal women with primary osteoporosis (age 61.0±4.8 (M±σ) years) was administered alendronate in dosage 70 mg weekly with calcium supplementation (1000 mg daily) for 12 months. Control group consisted of 19 women also suffered from postmenopausal osteoporosis (age 61.7±5.2 years) received only calcium salts for study period.
There was a significant increase vs baseline in BMD in lumbar spine (in 2.1% in 6 months and in 2.7% in 12 months), in femoral neck from (in 2.1% and 3.3% accordingly), in trochanter (in 5.5% and 6.3% accordingly) and in total proximal femur (in 2.9% and 1.9% accordingly) in treated patients. We also found in treated group a marked decrease in serum ionized calcium from 1.24±0.03 to 1.21±0.03 mmol/l in 6 months and to 1.2±0.04 mmol/l in 12 months (р<0.05 vs baseline), in alkaline phosphatase from 98.7±44.8 to 63.5±15.6 u/l in 6 months (р<0.05 vs baseline) and to 60.7±13.8 u/l in 12 months (р<0.05 vs baseline and p<0.0001 vs control), in osteocalcin from 28.0±8.7 to 23.4±10.4 ng/ml in 6 months and to 20.3±8.2 ng/ml (p<0.05 vs control), and in urinary calcium/creatinine excretion and daily calcium excretion. Back pain and quality of life significantly improved in treated group, and regimen of alendronate dosing was highly convenient in all patients' opinion. Tolerability of alendronate was satisfactory but 3 patients stopped the treatment due to gastrointestinal side effects.
Those results demonstrate that alendronate in dosage 70 mg weekly increases BMD, decreases serum and urinary calcium and bone turnover markers, improved back pain and quality of life and is at satisfactory tolerability in women with postmenopausal osteoporosis.
About the Authors
A V DREVAL'L A MARChENKOVA
I V KRYuKOVA
R S TIShENINA
L M PORTNOY
N M MYLOV
M P RUBIN
References
1. Дедов И.И., Рожинская Л.Я. Роль и место бисфосфонатов в профилактике и лечении остеопороза 10-летний опыт применения алендроната (фосамакса). Обзор литературы // Остеопороз и остеопатии. 2005; 1:20-30.
2. Клинические рекомендации «Остеопороз. Диагностика, профилактика и лечение (Под ред. Л.И. Беневоленской, О.М. Лесняк) // М.: ГЭОТАР-Медиа, 2005. 176 с.
3. Рожинская Л.Я., Дзеранова Л.К. и др. Результаты лечения постменопаузального остеопороза бисфосфонатом - фосамаксом // Остеопороз и остеопатии. 1998; 2:28-32.
4. Торопцова Н.В., Беневоленская Л.И. Уровень витамина Д в сыворотке крови у женщин в постменопаузе // Тезисы II Российского конгресса по остеопорозу, Ярославль, 29 сентября-1 октября 2005 г: 97-98.
5. Скрипникова И.А., Косматова О.В. и др. Результаты длительного лечения постменопаузального остеопороза бисфосфонатом - фосамаксом // Остеопороз и остеопатии. 2004; 1:16-19.
6. Скрипникова И.А., Косматова О.В. и др. Результаты открытого многоцентрового исследования эффективности и переносимости фосамакса 70 мг 1 раз в неделю при постменопаузальном остеопорозе // Остеопороз и остеопатии. 2005; 3:34-37.
7. Bell N.H., Bilezikian J.P., et al. Alendronate increases bone mass and reduces markers in postmenopausal African-American women // J. Clinical Endocrinology Metabolism 2002. Jun; 87(6): 2792-7.
8. Bone H.G., Hosking D., et al. Ten years' experience with alendronate for osteoporosis in postmenopausal women // New England J. Medicine, 2004. Vol. 350: 1189-1199.
9. Greenspan S., Fild-Munves E., et al. Tolerability of once-weekly alendronate in patients with osteoporosis: a randomized, double-blind, placebo-controlled study // Mayo Clinic Proccedings, 2002. Vol. 77: 1044-1052.
10. Massari F., Zanchetta S.R., et al. PTH levels in posmenopausal women with osteoporosis treated with alendronate. // J. Bone Mineral Research, 1997. Vol. 12 (Suppl 1): 470.
11. Nordin B.E.C. Calcium, phosphate and magnesium metabolism. Edinburgh, 1976. P.469-500.
12. Pols H.A., Felsenberg D., et al. Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study // J. Osteoporosis International, 1999. Vol.9(5): 461-468.
13. Rizzoli R., Greenspan S.L., at al. Two-years results of once-weekly administration of Alendronate 70 mg for the treatment of postmenopausal osteoporosis // J. Bone Mineral Research, 2002. Vol. 17: 1988-1996.
14. Schnitzer T., Bone H.G., et al. Therapeutic equivalence of alendronate 70 mg once weekly and alendronate 10 mg daily in the treatment osteoporosis // Aging Clinical Experimental Research, 2000. Vol. 12: 1-12.
15. Simon J.A., Lewiecki E.M., et al. Patient preference for once-weekly 70 mg versus once-daily 10 mg: a multicenter, randomized, open-label, crossover study // Clinical Therapeutics, 2002. Vol. 24: 1871-86.
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For citations:
DREVAL' A.V., MARChENKOVA L.A., KRYuKOVA I.V., TIShENINA R.S., PORTNOY L.M., MYLOV N.M., RUBIN M.P. EFFEKTIVNOST', PERENOSIMOST'I KOMPLAENTNOST' ALENDRONATA NATRIYa(70 MG 1 RAZ V NEDELYu)PRI LEChENII POSTMENOPAUZAL'NOGO OSTEOPOROZA. Osteoporosis and Bone Diseases. 2006;9(2):13-17. (In Russ.)
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