[Vitrum osteomag in prevention of osteoporosis in postmenopausal women: results of the comparative open multicenter trial].
OBJECTIVE
To investigate efficacy, tolerance and safety of the drug vitrum osteomag one tablet of which contains 600 mg calcium (1500 mg calcium carbonate), 200 IU of cholecalcepherol, 40 mg of magnesium, zinc (7.5 mg), copper (1 mg), manganese (1.8 mg) and boron (250 mcg) in women with osteopenia for prevention of osteoporosis.


METHODS
A multicenter comparative open trial of vitrum osteomag influence on mineral bone density (MBD), change of pain syndrome in bones, index of calcium-phosphorous metabolism covered 334 postmenopausal women with osteopenia. MBD was measured in low-back spine and proximal part of the hip with DEXA method. All the patients were divided into 3 groups: 125 women taking 2 tablets of vitrum osteomag daily for 12 months (group 1); 111 women taking 1500 mg calcium carbonate (group 2); 96 women--control group (only observation).


RESULTS
Vitrum osteomag relieved pain in the back and joints, had a positive effect on bone density (+1.5%) and proximal parts of the hip (0.6-0.93%) exceeding the effect of calcium carbonate only which preserves the initial MBD in low back spine but does not prevent bone loss in the hip. MBD dynamics in patients given vitrum osteomag differs essentially from one in the control group (from -1.9 to -2.91%) which demonstrates a reliable preventive anti-osteoporotic effect of this medication. The drug increases the level of general and ionized calcium in blood but does not cause hypercalcemia lowering the level of parathormone in blood. The rate of side effects in group 1 was 14.4% and did not differ much from that in group 2 (16.2%).


CONCLUSIONS
The results of the study allow to recommend vitrum osteomag for prophylaxis of a rapid loss of bone tissue mineral density.
Benevolenskaia
L I
LI
Toroptsova
N V
NV
Nikitinskaia
O A
OA
Sharapova
E P
EP
Korotkova
T A
TA
Rozhinskaia
L Ia
LIa
Marova
E I
EI
Dzeranova
L K
LK
Molitvoslovova
N N
NN
Men'shikova
L V
LV
Grudinina
O V
OV
Lesniak
O M
OM
Evstigneeva
L P
LP
Smetnik
V P
VP
Shestakova
I G
IG
Kuznetsov
S Iu
SIu
D015502:Absorptiometry, Photon; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D002118:Calcium / Q000097:blood; D002119:Calcium Carbonate / Q000008:administration & dosage; D002762:Cholecalciferol / Q000008:administration & dosage; D019587:Dietary Supplements; D005260:Female; D005269:Femur / Q000000981:diagnostic imaging / Q000187:drug effects; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000187:drug effects; D008274:Magnesium / Q000008:administration & dosage; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000517:prevention & control*; D010281:Parathyroid Hormone / Q000097:blood; D014131:Trace Elements / Q000008:administration & dosage
D010281:Parathyroid Hormone; D014131:Trace Elements; D002762:Cholecalciferol; D002119:Calcium Carbonate; D008274:Magnesium; D002118:Calcium