Osteo-Vit D3 for children with reccurent fractures at osteoporosis treatment

 

 

Osteo-Vit D3 for children with reccurent fractures at osteoporosis treatment

 T.A. Kuptsova,  A.I. Kyslov, V.I. Strukov, D.G. Elistratov, L.A. Balykova, I.A. Golovin

 

 

State-financed health institution

«Penza Medical Refresher Institute of Russia Ministry of Health»

Federal State-Funded Educational Institution of Higher Professional Education «Penza state university»

 

 

Actuality. Osteoporosis is a multifactorial metabolic disease of skeletal system, characterized by bone mass per unit volume reducing, bone microarchitectonics disorder that leads to excessive brittleness of bone and its fracture [1]. Bone fracture – it is an integral indicator of osteoporosis. As a rule, bone fractures are non-traumatic (pathological) at osteoporosis, which is characterized by bone injury with solution of its continuity in the area of ​​abnormal reconstruction arising from the inadequate strength of injury impact or without it.

Interest in the problem of children osteoporosis is noted even in the middle of the 20s century. In the doctor-endocrinologist C. Dent report in 1973 was the information that “Senile osteoporosis is a pediatric disease.” Despite this, for a long time osteoporosis was considered a disease of older people only, which was associated with bone mass loss. At the present moment, this view is reconsidered. In the works of many scientists (Schepliagina L.A., Kruglov I.V., Moiseieva T.Y.) shows that the adult osteoporosis roots lie in childhood.

It is known that peak bone formation in children is a genetically programmed process [2]. The target program is to reach not only the programmed linear body size, but also bone mineral density, morphofunctional and anthropometric indicators. Their tight fit ensures the growing organism harmonious development. However, under the influence of various endogenous and exogenous factors there is a possibility of the genetic program bone tissue abnormalities both before and after the birth. Osteopenia and osteoporosis form under these conditions. Table 1 shows the main reasons foster the development of osteoporosis in adults and children, based on the literature and our own research.

 

Table 1

 

The main factors, that promote children OP development

 

Life cycle	OP development factors
Antenatal life	Hypoxic-ischemic fetus involvement, the calcium transport in the mother-placenta-fetus system disorder, pregnancy associated with chronic mother’s diseases (disorders ща renal, endocrine system, gastrointestinal tract, etc), Pregnancy with the mother’s osteopenia, mother bad habits, social factors (poor living conditions, low income), mother occupational hazards
Tender age	Artificial feeding, prematurity, multiple pregnancy, thyroiditis (including transient), fat-soluble vitamins in the intestinal canal poor absorption (premature babies), lack of biligenesis, D hypovitaminosis, ultraviolet  irradiation deficit, polyhypovitaminosis
Elderly childhood and adolescence	Lack of health care maintaining, unhealthy diet, protein, dairy products deficiency, ultraviolet and vitamin D deficit, low calcium in the diet, lack of physical activity, gastrointestinal tract, kidney, liver diseases, rheumatic diseases, endocrine diseases, bad habits, industrial toxins, radionucleins.
Iatrogenic osteopenia	Steroid hormones with systematic administration, thyroid hormones, anticonvulsants, phenobarbital, heparin (long-term therapy for more than 3 months.), chemotherapeutic drugs, chronic use of antacids (especially aluminum-containing), radiation therapy, tetracycline, cyclosporine, gonadotropin

Note: OP – osteoporosis

 

All of these factors have negative influence on the bone peak formation, assist various functional abnormalities, which may develop in pathological osteohalisteresis, osteoporosis, the risk of bone fractures and deformities, both at a young and elderly age. Thus, there is a definite dependence of osteoporosis development in adults on of bone mass in childhood and adolescence accumulation [3].

 

There is a trend growth rate of fractures throughout the entire world since 1990, not only because of population greying, but also because of the disease rejuvenescense of the disease [4]. According to many scientists, osteoporosis acquired the character of epidemy at the present time that affects the child population too. Currently children osteoporosis is underinvestigated. There is no original drugs for disease prevention and treatment for children. Therefore, the development and insertion of medical products, including dietary supplements, and analysis of their efficiency is a requirement for nowadays.

 

Children osteoporosis classification is also underinvestigated. Therefore, the classification of children and adolescents osteoporosis was suggested by us (Strukov et al.)  (see. Table. 2).

 

Table 2

 

Children and teenager osteoporosis classification

 

Stages	congenital, acquired
Prevalence rate	systemic, local
By the nature of trabecular bone morphometric changes	with cavitary lesions and without them
Bone mineral density	low, normal, high
Age of bone fracture occurrence after the birth	before pubertal ( till 12 years), pubertal (12-14 years), after pubertal
Fractures localization	typical and atypical

 

 

Presented classification allows traumatologists and pediatricians to orientate in this issue and carry out cooperative treatment of patients, taking into account not only the level of bone mineral density, but also the age, and morphometric data.

 

Goals of research. To examine children with recurrent bone fractures. To study etiological structure of children recurrent fractures. To investigate the effectiveness of the children recurrent fractures treatment by osteoprotector «Osteo-vit D3».

Investigation materials and methods

 

Our study is an open, prospective, randomized. It was conducted in accordance with the “Rules of the quality of clinical trials” (OST №42 from 29.12.1998), with the order №103 dated 24.03.2000 “About the clinical research conduct”.

From 2013 to 2014 47 children aged 9-17 years with recurrent fractures of long cylindrical bones was examined on the base of osteoporosis center. 22 children has normal or even increased (in 2 children) bone mineral density (BMD) at x-ray absorptive osteometry. These children formed an exception group.

The children with recurrent fractures and with low bone mineral density at the same time (less than -2.0 CO of Z-criterion, on the recommendations of the American Association on Osteoporosis) were the inclusion criteria – only 25 patients, the main cohort of the research. There are 13 girls (52 ± 10%) and 12 boys (48 ± 10%) from them. There are mainly urban dwellers: the city is home to 23 children, in the village – 2.

At assessing the comparative effectiveness and safety of medications the following methods were used. All the children interviewed personal history of the disease and analysis of outpatients’ cards (f.112), an objective examination was carried out. Clinical blood and urine tests was made from laboratory methods, determination of the total content of calcium, phosphorus, protein, alkaline phosphatase, parathyroid hormone, test deficiency of Vitamin D – calciferol 25 (OH) D. From the radiological methods – X-ray of the bones in the fracture area, bone mineral density determination by x-ray absorptive on “OSTEOMETER DTX-100” (in contrast to the DTX-200 it allows you to determine bone mineral density and morphometry at the same time) before and after treatment. The statistical processing of research material was carried out using the package of program «Statistica 12.0», the average M ± m determined, p is an indicator of the significance of differences.

 

Results and its discussion. From trauma medical history revealed that throughout the life of 9 children (36 ± 10%), there were two fractures of long cylindrical bones, 6 children (24 ± 9%) have three, 6 children (24 ± 9%) have four, 4 children (16 ± 7%) have five. We found from anamnesis that children cylindrical bone fractures occur as a result of inadequate exposure of the strength of the traumatic factor (a fall from the height of children growth, hit the things). Repeated radius fractures were observed at 14 children (56% ± 11%), the ulnar bone fractures has 8 children (32 ± 10%), and both forearm bones fractures (3 children, 12 ± 10%).

At assessing the mineral metabolism, most children has total calcium level (17 children, 68% ± 9%) and phosphorus (16 children, 64 ± 10%) are in the normal range (normal total calcium 2,2-2, 7 mmol / l, phosphorus 1,45-1,78 mmol / l Tietz, 1997 YG) in the biochemical analysis of blood. It was also found that the vitamin D status of children with bone mineral density disorder and recurrent fractures is insufficient at 9 children (36 ±%;. Vitamin D in the range of 21 to 29 ng / ml) is deficient at 16 children (64 ± 10%; vitamin D less than 20 ng / ml). The level of parathyroid hormone is increased at 18 children, more than 40.4 pg / ml (78% ± 9%).

All children received treatment and traumatologist and pediatrics monitoring. The children of the main contingent are divided into two comparable groups by the method of medical treatment: I group – 13 children (receiving treatment course “Osteo-Vit D3» 1 pill 2 times per day for 3 months 3 times a year, interchanging with 1 month interval) II group – 12 children (receiving a therapy course “Calcemin” 1 tablet 2 times a day for 3 months 3 times a year with 1 month interval).

“Osteo-Vit D3” tablet composition: 100mg male bee brood, the D3 vitamin – 300 IU, vitamin B6 – 0.8 mg. Drone brood chemical composition: 10-20% proteins, carbohydrates, 1-5.5%, 5-6.3% fats, amino acids 11.4%, 3,18-5% glucose, fructose and sucrose up to 0.5%. Micronutrients (mg%): K 0,5, Na 38 Ca 14 189 P, Mg 2, Fe 3.23, Mn 4.4, 5.54 Zn, Cu 2. Vitamins: A 0.54 IU / g , xanthophyll 0.297 mg %, B-carotene 0.426 IU / g 0.739 B2 mg%, D 950 IU / g, choline 442.8 mg%, nicotinic acid 15.8 mg%. Composition of amino acids: lysine, histidine, arginine, aspartic acid, threonine, serine, glutamic acid, proline, glycine, alanine, valine, methionine, isoleucine, leucine, tyrosine, phenylalanine, cysteine.

The effectiveness of therapeutic treatment was evaluated by densitometry results after 12 months. In the first group, BMD significantly increased from -2,8 ± 0,2 CO to CO -1,7 ± 0,15 (p <0.05). In the second group was also a BMD increase from -2,9 ± 0,3 till -2,4 ± 0,6 CO, but to a lesser degree (p> 0.05). There was no recurrent bone fractures in both groups within a year.

Thus, the received results of the study allow us to consider “Osteo-vit D3” as highly effective in the prevention and treatment of children recurrent bone fractures. It is important to note that “Osteo-vit D3” is the only home produced D3 vitamin containing product and it is highly competitive with the foreign drug “Calcemin”.

Conclusions

 

1. “Osteo-vit D3” is an effective drug for the recurrent fractures on the background of children low bone mineral density treatment.
2. Refracture on a background of low bone mineral density is an important diagnostic feature of osteoporosis.
3. There is a need of the further research of “Osteo-vit D3” and its composition improvement for the development of effective preventive measures of vitamin D deficiency and diseases developing because of its deficit.

 

Bibliography

 

1. Peterkova V. A., Korovin N. And. Calcium deficiency and osteopenic conditions in children: diagnosis, treatment, prevention. The international Fund of protection of mother and child // Scientific and practical program. – 2006. – P. 48.
2. Shalygina L. A., Kruglov V. I., Moiseeva T. Y. the Origins of osteoporosis are in children // Pediatrics. – 2013. – No. 1.- P. 5-11.
3. Strukov, V. I. Actual problems of osteoporosis. – P.: Rostra, 2009. – 341 p.
4. Shilin D. E. Epidemiology of fractures in children: rationale for pharmacological correction of calcium deficiency and vitamin D // Pediatrics. – 2007. – No. 3. – Р. 70-78.