Vol 22, No 1 (2019)

Original study
Comprehensive assessment of the pharmacokinetic properties of a single bolus dose of colecalciferol in terms of efficacy and safety
Suplotova L.A., Avdeeva V.A., Pigarova E.A., Rozhinskaya L.Y.

Background: The lack of a unified approach to the treatment of deficiency and vitamin D deficiency stimulated a detailed study of the dynamics of indicators of phosphorus-calcium metabolism, parathyroid hormone, 25(OH)D (calcidiol).

Aim: To evaluate the pharmacokinetic properties of colecalciferol at a dosage of 150 000 IU, from the standpoint of its efficacy and safety in clinical practice.

Materials and methods: Observational, single-center, prospective, selective, uncontrolled study of a comprehensive assessment of the pharmacokinetic properties of a single saturating dose of 150 000 IU of colecalciferol. To assess the pharmacokinetic properties of colecalciferol at a dosage of 150 000 IU, we set efficacy and safety criteria. The criterion for the effectiveness of treatment was to achieve an adequate level of vitamin D (more than 30 ng / ml at the initial insufficient level and more than 20 ng / ml for patients with vitamin D deficiency). The safety criteria for the correction of vitamin D deficiency or deficiency were the absence of patient complaints, adverse events and / or serious adverse events, as well as the preservation of the main laboratory parameters of phosphorus-calcium metabolism within the reference values.

Results: When studying the efficacy of a dose of 150 000 IU in patients with vitamin D deficiency and insufficiency, it was found that the level of calcidiol was significantly higher in the group after treatment with colecalciferol compared with the group before treatment (p <0.05). The peak of the maximum value for patients with deficiency was established on the 14 day from the moment of administration of colecalciferol and was 37.1 ± 6.28 ng / ml, and for patients with initial vitamin D deficiency 40.1 ± 3.71 ng / ml. In the study of the safety of colecalciferol in a bolus dose of 150 000 IU, there were no statistically significant differences in the laboratory parameters of calcium-phosphorus metabolism, both in the group before treatment and after correction of deficiency and vitamin D insufficiency in both groups.

Conclusion: Colecalciferol in the form of a single bolus dose of 150 000 IU demonstrated its efficacy and safety in real clinical practice.

Osteoporosis and Bone Diseases. 2019;22(1):4-9
Evaluation of diagnostic potential of the collagen osteogenesis marker (P1NP) compared with osteocalcin in Cushing’s disease
Tsoriev T.T., Belaya Z.E., Rozhinskaya L.Y., Nikankina L.V.

Background: Secondary osteoporosis is a significant problem, especially in patients with endocrine pathology, which is not accompanied constantly by distinct clinical symptoms. Markers of bone origin are needed, which could be used in osteoporosis diagnosis to clarify its genesis, especially in young people who have secondary osteoporosis more often than older patients. In Cushing’s disease (CD), such a marker, in addition to osteocalcin, could be another bone formation marker, procollagen type 1 N-terminal propeptide (P1NP).

Aims: To study the diagnostic potential of P1NP as an additional marker of endogenous hypercortisolism (Cushing’s disease) compared to osteocalcin.

Materials and methods: The study involved patients with Cushing’s disease and healthy volunteers, matched by gender, age, and body mass index. The levels of osteocalcin and P1NP were assessed in both groups, the electrochemiluminescence method for P1NP (Cobas e411 (Roche, Switzerland)) and for osteocalcin (Cobas 6000 Module e601 (Roche, Switzerland)) was used. ROC analysis was performed with the calculation of sensitivity and specificity of the method to determine the cut-off point for P1NP in CD diagnosis.

Results: 29 patients with Cushing’s disease and 27 healthy individuals from the control group were included in the study. There were no differences in age, sex and body mass index (p = 0.488, 0.426 and 0.531, respectively). Both studied bone formation markers (osteocalcin and P1NP) were reduced in patients with CD: 8.53 ng/ml (Q25%;Q75% 5.40; 12.41) versus 22.45 ng/ml (Q25%;Q75% 17.36; 26.31) (p <0.001) and 28.50 ng/ml (Q25%;Q75% 18.00; 44.00) versus 56.50 ng/ml (Q25%;Q75% 39.50; 65.50) (p <0.001), respectively. The area under the receiver operating characteristic curve (AUC) was 0.808 (95% CI 0.693–0.924) for P1NP and 0.925 (95% CI 0.857–0.992) for osteocalcin, that indicates the greater diagnostic value of osteocalcin for CD verification in healthy controls. Optimal cut-off points were obtained: 53.4 ng/ml (values below are more typical for patients with CD; sensitivity of the method is 96.55%, specificity 57.69%) for P1NP and 15.285 ng/ml (below for patients with CD; sensitivity was 92.59%, specificity 77.78 %) for osteocalcin.

Conclusions: The diagnostic potential of osteocalcin to detect Cushing’s disease in the population is higher compared to P1NP. However, applying of P1NP can be useful because, unlike osteocalcin, it is a direct indicator of the formation of bone matrix collagen structures, that is important for assessing the degree of inhibition of collagen type 1 synthesis in CD and deterioration of bone tissue due to glucocorticoid-induced osteoporosis.

Osteoporosis and Bone Diseases. 2019;22(1):10-17
Case report
A case of atypical femur fracture during long-term treatment with bisphosphonates in patient with postmenopausal osteoporosis
Zotkina K.E., Lesnyak O.M., Kochish A.Y., Sushkov I.V.

Bisphosphonates is a first-line therapy for treatment of osteoporosis. In the last decade, the number of atypical femur fracture (AFF) cases during long-term treatment with bisphosphonates has increased. The aim of this article was to analyze the literature data on this problem, to define the diagnostic criteria of AFF and to present the case of AFF in the patient who received treatment with alendronate for 3.5 years.

A 78-year-old woman, receiving oral bisphosphonate for severe postmenopausal osteoporosis for 3.5 years, suddenly started feeling pain in her right thigh while walking. Three months later, she had got a fracture in middle third of the right femur after falling from her standing height. According to instrumental diagnostics, this fracture had all criteria of AFF. Blocking intramedullary osteosynthesis with shafts was performed. A retrospective analysis of soft tissue magnetic resonance imaging in the area of right thigh, done before the fracture, showed the presence of undiagnosed incomplete right femur fracture in the middle third, which subsequently led to a complete fracture.

Presented clinical case demonstrates the complexity of AFF diagnostics. The purpose of the publication is to draw attention of medical specialists to the issue of this rare side effect of bisphosphonate treatment.

Osteoporosis and Bone Diseases. 2019;22(1):18-23
Clinical application experience of asfotase alfa for a young patient with childhood hypophosphatasia
Kalinchenko N.Y., Golounina O.O., Grebennikova T.A., Melnichenko G.A., Tiulpakov A.N., Belaya Z.E.

Hypophosphatasia (HPP) is a rare hereditary metabolic disease characterized by defective bone and dental mineralization, systemic complications that lead to disability of patients. HPP is classified into six forms according to the age of onset and severity of its clinical picture. The disease is caused by a reduced activity of the tissue nonspecific alkaline phosphatase (TNSALP) and elevated concentrations of pyrophosphates. Asfotase alfa is the only pathogenetic enzyme replacement therapy with recombinant human bone-targeted TNSALP approved for treatment of patients with perinatal, infantile and juvenile‐onset HPP. This treatment is associated with improved skeletal mineralization, respiratory function and overall survival in infants and young children with life-threatening hypophosphatasia. The world experience in application of recombinant alkaline phosphatase in adults is very limited. We present a clinical case that describes the first Russian experience in the use of asfotase alfa in an 18-year-old patient with late diagnosis of childhood-onset HPP.

Osteoporosis and Bone Diseases. 2019;22(1):24-29
21st European Congress of Endocrinology. A review of reports on calcium and phosphate metabolism, osteoporosis and other bone diseases
Eremkina A.K.

On May 18-21, 2019, the 21st European Congress of Endocrinology was held in Lyon (France), bringing together a record number of participants - more than 4,000 specialists from Europe, the USA, Canada, Israel, Saudi Arabia, Russia and the CIS countries . The past congress is an extremely important event in the endocrinological scientific community, providing an opportunity to learn about the latest achievements in the field of endocrinology and fundamental medicine from leading world experts, researchers and clinicians. Traditionally, the European Endocrinology Congress discusses the most pressing issues, including those related to the latest developments in the field of diabetology, thyroidology, obesity, reproductive endocrinology, neuroendocrinology, medical genetics, etc. In addition, this year, the problem of the pathology of phosphorus-calcium metabolism was widely covered, from the most common diseases of primary hypeptarthrosis and osteoporosis to rare genetically determined bone diseases.

Osteoporosis and Bone Diseases. 2019;22(1):30-33
Leonid Borisovich Reznik. Obituary

The Russian Osteoporosis Association, the editors of the journal Osteoporosis and Osteopathies, regretfully report that on May 26, 2019, a famous Russian doctor, professor, doctor of medical sciences, chief freelance traumatologist of the Omsk region Leonid Borisovich Reznik, passed away.

Osteoporosis and Bone Diseases. 2019;22(1):34-34

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