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Registration Number

0215U000461, 0112U000526 , R & D reports

Title

Develop a complex program of diagnosis, prevention and treatment of vitamin D deficiency and deficiency in older and elderly patients with pathology of the musculoskeletal system

Head

Povoroznjuk Vladislav V., Доктор медичних наук

Registration Date

25-02-2015

Organization

State Institution "Institute of Gerontology AMS Ukraine"

Description

The purpose of the study - based on the peculiarities of the musculoskeletal system diseases in older and elderly patients with vitamin D deficiency to develop, test and implement a complex program of diagnosis, prevention and treatment of such pathology. Methods: orthopedic examination; questionnaire (VAS, ECOS-16 EuroQool-5D, Roland-Morris, index Lequesne, risk factors for osteoporosis and fractures); anthropometric studies; DXA (L1-L4, forearm, dual femur, total body); X-ray thoracic, lumbar spine, morphometry; biochemical blood tests (calcium, phosphorus, alkaline phosphatase, liver and kidney profile, lipid profile), biochemical analysis of urine (calcium/creatinine ratio), electrochemiluminescence assay method, 25(OH)vitamin D, intact parathyroid hormone). Materials: 1208 men and women aged 50-90 years were examined to study the frequency of vitamin D deficiency in old and elderly patients with musculoskeletal system diseases. To study the influence of vitamin D deficiency to the course of musculoskeletal system diseases there were examined 83 patients with primary osteoarthritis of large joints and 283 patients with systemic osteoporosis. To study the effectiveness of active metabolites of vitamin D (alfacalcidol) were examined 20 women with systemic postmenopausal osteoporosis and vitamin D deficiency. To study the effectiveness of therapy of combined calcium and vitamin D medicine (1 000 mg of calcium and 400 IU of vitamin D) were examined 20 postmenopausal women with systemic postmenopausal osteoporosis. To study the effectiveness of fortified bread in the correction of vitamin D deficiency there were examined 52 postmenopausal patients who took the fortified product (25 mg cholecalciferol in 277 grams of bread). To investigate the effectiveness of targeted vitamin D therapy there were examined 70 postmenopausal women aged 50-87 years with musculoskeletal system diseases. It was found that patients of older age groups (50-89 years) with the musculoskeletal system diseases, vitamin D deficiency (VDD) is recorded in 80.3% of cases (of which 46.9% - severe VDD), 13 6% had vitamin D insufficiency, and only 6.1 % of the patients have the optimal level of blood 25(OH)D. 25(OH)D level in women was significantly lower (29,9±22,1 nmol/L) compared to males (38,6±22,5 nmol/L) (p<0.0001). However, such peculiarity is observed only in the age group 50-59 years. 25(OH)D level is decreasing in serum: mean blood 25(OH)D level in the age group 80-89 years is 25,8±18,0 nmol/l and is significantly lower in comparison with the group 50-59 years (32,6±23,3 nmol/L) (p <0.01) and 60-69 years (31,0±20,9 nmol/L) (p<0.05). Also found that obesity patients (BMI>35.0 kg/m2) have significantly lower blood 25(OH)D levels (26,1±16,2 nmol/L) compared to those with normal (34,3±25,3 nmol/l) increased body weight (31,2±21,9 nmol/L) or mild obesity (29,6±22,1 nmol/l). It was found that the lowest 25(OH)D level in patients with musculoskeletal system diseases is recorded in February (22,6±15,9 nmol/l) and March (20,8±15,7 nmol/l, in 80-89 years group the lowest level (10,0±22,1 nmol/l) was recorded from February to May. Vitamin D deficiency is recorded in 79.5% of patients with osteoarthritis of the large joints. The pain syndrome in patients with moderate and severe vitamin D deficiency is significantly higher compared with a group with 25(OH)D above 50 nmol/l (39,2±6,6 and 57,8±11,8 against 22,4±8,1 points (p<0.05)). Quality of life (due to EuroQoL-5D scale) in patients with a 25(OH)D above 50 nmol/L was significantly lower compared with in patients with vitamin D deficiency (p<0.05). In patients with systemic osteoporosis vitamin D deficiency is recorded in 80.7 % of patients. The frequency of secondary hyperparathyroidism is 13.9%. The intensity of pain in the lumbar spine is significantly higher in patients with severe and moderate vitamin D deficiency and is 43,1±3,51 and 45,4±3,63 points against 14,0±1,4 points in patients with normal 25(OH)D level (p<0.05). Quality of life of patients with normal vitamin D is significantly lower in comparison with the groups with severe and moderate vitamin D deficiency (p<0.05). The vitamin D active metabolites treatment of systemic osteoporosis in postmenopausal women with vitamin D deficiency during 12 months contributes to a significant decrease intact parathyroid hormone levels (from 49.42 [35.16, 65.87] to 38.85 [21.91; 54.98 ] pg/ml (p 0,05)), reduce the risk of falls, the severity of vertebral pain and improve the quality of life of patients (p 0,05). Combined calcium and vitamin D medicines (1000 mg calcium and 400 IU of vitamin D) within three months causes a significant increasing of the blood vitamin D level in postmenopausal women with osteoporosis system (from 32.35 [20.8, 54, 9] to 46.1 [33.8; 52.5] nmol/L (p<0,05)), as well as reduces the intensity of vertebral pain syndrome in the lumbar spine (from 39.0 [25.0; 55 5] to 33.0 [16.0; 48.0]) points, respectively (p <0,05). To study the safety and efficacy of fortified bread in correction of vitamin D status in postmenopausal women. It was developed high-fiber baked bread with a cholecalciferol concentration of 25 µg per 277 g. 30 postmenopausal women aged 45-80 years old were included to the study. Patients with malignant disease; with renal, hepatic, or gastrointestinal disorders; with endocrine disease associated with abnormal calcium metabolism that required therapy; who had used estrogen, progesterone, glucocorticoids, anticonvulsants, vitamin D supplements were not permitted for inclusion. The serum levels of calcium, phosphor, alkaline phosphatase, and lipids levels were evaluated for safety reasons. All subjects were subdivided into two groups: first one included 20 women (60.9±8.97 yrs. old, BMI - 29.21±5.42 kg/m2) who took fortified bread and second, control group, consists of 10 women (68.12±7.70 yrs. old, BMI - 30.64±4.89 kg/m2) which took bread without cholecalciferol. The duration of the study lasts 21 days. Intake of fortified bread has facilitated a significant increase in 25(ОН)D levels. In women with vitamin D deficiency the mean level of blood 25(OH)D increased from 14.20±2.60 to 20.05±2.74 ng/ml (p<0.001). In subjects with vitamin D insufficiency consumption of fortified bread leads to rising of blood 25(OH)D level from 22.50±1.6 tо 26.03±1.90 ng/ml (p<0.01). In control group it wasn't significant increasing of blood 25(ОН)D level (17.12±8.08 at baseline and 17.44±8.33 ng/ml in 3 weeks). Fortified bread leads to ionized calcium increase (р=0,03) in blood serum (from 1.23±0.04 to 1.25±0.04 mmol/L), but we didn't see anyone with hypercalcemia. Also, it wasn't registered any adverse events in examined subjects. To assess the efficacy and safety of individual targeted vitamin D therapy in postmenopausal women with skeletal diseases (systemic osteoporosis and osteoarthritis). Due to high prevalence of vitamin D deficiency in Ukraine it was developed the individual targeted therapy of vitamin D deficiency. The individual targeted therapy consists of two periods - saturation period and maintenance therapy period, during which patients take it constantly. Duration of saturation therapy is calculated by the formula: Saturation therapy duration (days) = (100 - VDL) х BW/100, Where: VDL is blood 25(ОН)D level (ng/mL), BW is body weight (kg). The therapy for saturation includes combined calcium (1000 mg of calcium and 800 IU of vitamin D) and 3000 IU of vitamin D per day. Maintenance therapy includes 2 000 IU of vitamin D per day. The study involved 70 postmenopausal women aged 46-87 years with skeletal diseases (systemic osteoporosis and osteoarthritis). All subjects were subdivided into two groups: main - 50 women who took individual targeted vitamin D therapy (50 subjects, 65.1±8.8 years old, BMI 27.22±4.51 kg/m2) and control (20 subjects, 64.5±11.1 years old, BMI 26.68±4.95 kg/m2). The duration of the treatment consists of 3 months starting on the 1st Oct 2013. The serum levels of calcium, phosphor, alkaline phosphatase levels were evaluated for safety reasons. In 3 months after the start of the treatment there was a significant (p<0.001) increase in 25(OH)D levels in the treatment group: 35.60±8.21 nmol/L as compared to baseline levels of 25.20±9.76 nmol/l. Remarkably, the treatment was most effective in the oldest subgroup (>70 yrs.), as well as in subjects with the BMI 25-28,99 kg/m2. After the treatment, there were no changes in calcium levels. The suggested individual targeted vitamin D therapy was proven to be effective in postmenopausal women. As the treatment turned out to be effective, relatively quick, and had a reasonable safety profile it may be beneficial for all vitamin D deficient postmenopausal women. The fortified bread has adequate taste, triggers significant 25(ОН)D level increase in serum and is not associated with adverse events development. Based on the Guidelines for the prevention and treatment of vitamin D deficiency for the population of Central Europe (2012), Guidelines of the International Association of osteoporosis (2013) and the results of our studies it was developed the algorithm of prophylactics and treatment of vitamin D deficiency for patients with bone and joint diseases.

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Балацька Наталія Іванівна
Бистрицька Марина Анатоліївна
Вдовіна Олена Андріївна
Гибало Надія Михайловна
Григор'єва Наталія Вікторівна
Гутор Алла Іванівна
Дзерович Наталія Іванівна
Дубецька Галина Сергіївна
Карасевська Тетяна Анатоліївна
Креслов Євгеній Олександрович
Крочак Святослава Петрівна
Мусієнко Анна Сергіївна
Муц Віктор Ярославович
Орлик Тетяна Василівна
Паламарчук Алла Внатоліївна
Парахіна Тетяна Володимирівна
Поворознюк Василь Валерійович
Синенький Омелян Володимирович
Солоненко Тетяна Юріївна