Diagnostic technique for osteoporosis, method for testing cavitary lesion closure behaviour for assessing effective use of various osteoprotectors

FIELD: medicine.

SUBSTANCE: invention refers to medicine, diagnostics, assessment of the efficacy of osteoporosis medications. Diagnosing osteoporosis and controlling the progression thereof are implemented by X-ray absorption method using an osteometers; a diagnostic criterion of osteoporosis is the presence of cavitary lesions in trabecular bones; the lesion closure behaviour enables stating the efficacy of the medication or medications.

EFFECT: method provides the objective diagnosis of osteoporosis and assessment of the effective action of the osteoprotective medication or medications, with assessment of a severity of the disease not by mineral density, but by the presence of the cavities in the trabecular bones.

3 dwg, 3 ex

 

The invention relates to the field of medicine to diagnose osteoporosis and determine the effectiveness of preventive and curative effects on conditions associated with osteoporosis.

Osteoporosis (hereinafter OP) is a metabolic disease of the skeleton characterized by decrease in bone mass per unit volume and a violation of microarchitecture of bone tissue, with the formation of bone porozni formations, leading to a decrease in the amount of calcium in the bones and high risk of fracture of any bone, including the femoral neck.

In the prior art it is known that for the prevention and treatment of osteoporosis uses a great number of drugs are mainly imported. They can be divided into three large groups:

drugs that suppress bone resorption:

- estrogenic hormones (Devin, divigel, devitre, estrofem, klimen, klimonorm, tibolone, and others),

calcitonin,

- bisphosphonates (alendronate, clodronate, aclasta others),

- calcium,

- vitamin D (calciferol, cholecalciferol),

active metabolites of vitamin D (calcitriol, alfacalcidol),

- thiazide diuretics,

- ossein - hydroxyapatite,

- anabolic steroids (Oxandrolone, nandrolone, stanozol);

drugs that increase bone mass:

derivatives of fluoride (sodium fluoride, monofluorophosphate),

p> - anabolic steroids

- ipriflavone,

- ossein - hydroxyapatite,

- peptide (1-34), PTH,

- prostaglandin Eh,

the hubbub of growth

- parathyroid hormone;

tools that affect both of these processes:

- vitamin D: cholecalciferol (D3), ergocalciferol (D2),

active metabolites of vitamin D: calcitriol, alphadol (oksidevit, alpha D3-TEBA);

- the combination of calcium and vitamin D.

Widely used as mono and combination therapy drugs specified groups (ideas, calcium D3NYCOMED, alphadol calcium, calcium carbonate, calcium citrate and other).

Thus, in modern conditions, when offered hundreds of drugs practitioner it is difficult to choose an effective osteoprotegrin for the treatment of osteoporosis. Well placed advertising of these drugs, only complicates the choice of the drug. Therefore, development of methods for diagnostics of osteoporosis and ways to determine the effectiveness of the drug in treating the disease has actual value.

At the present time for the purpose of diagnosis OP and determine the effectiveness of therapeutic activity of drugs is a laboratory, histological, radiation methods. Histomorphologically analysis of biopsies of the iliac crest with the assessment of the activity of osteoclasts and osteoblasts considered earlier is more reliable in the diagnosis of OP. However, the invasive nature of these studies limits their use. So now for the diagnosis of osteoporosis and, therefore, to monitor the treatment uses radiation methods.

Standard radiography is one of the required methods. It allows you to conduct a morphometric analysis of the vertebral bodies, to identify the characteristic deformation of the vertebral bodies, with high precision to set the fractures of the vertebral bodies. Standard chest x-ray is the primary and most accessible method for diagnosing osteoporosis. However, this method of diagnosis is to late. Because you can identify osteoporosis only if the loss of bone mass more than 30-40%. Therefore, radiography for early quantitative diagnosis of osteopenia, osteoporosis and control therapy is unacceptable.

The most accurate and informative method of investigation of mineral bone density (BMD) is the x-ray absorptiometry. Company "Osteometr" developed a series of instruments to assess BMD at the distal forearm. Apparatus DTX-100, DTX-200 have special software for calculation of annual bone loss, can predict the risk of bone fractures. Modern osteometry measure BMD in different parts of the body, including the neck be the RA and the vertebral bodies. All osteometry work in two scales.

T-scale indicates the number of standard deviations above or below the average peak bone mass. T-score decreases in parallel with a gradual decrease in bone mass with increasing age and is used to assess BMD in adults.

Z-scale indicates the number of standard deviations above or below the average for persons of the same age. IPC is determined in absolute units, the standard deviations between the IPC age of the patient and normal healthy children and adolescents of the same age and sex.

In the prior art it is known that the determination of the severity of osteoporosis and the effectiveness of treatment outcomes evaluation study of the IPC according to the who classification:

Norma IPC - readings of the T-criterion from +1 to -1 standard deviations () of peak bone mass.

Osteopenia first degree - BMD between -1 and - 1.5 to WITH.

Osteopenia II degree - IPC from - 1.5 to - 2,0.

Osteopenia III - IPC-2.0-to 2.5 WITH.

Osteoporosis first degree - IPC - 2.5 and less without fractures.

Osteoporosis II degree - IPC - 2.5 and less in the presence of osteoporotic bone fractures.

Using these criteria currently being as diagnosis and determination of treatment effectiveness in one or another drug.

The disadvantage of this method

The decree is effective method takes into account only quantitative characterization of mineralization of bone, which, depending on the patient's body weight, region, gender, color may vary significantly from standard values. For example, women with low body weight, as a rule, have lower BMD than women with more weight, especially obesity, which complicates quantitative characterization of changes in osteoporosis. With this objective, a qualitative assessment of the effectiveness of the drug in the treatment of osteoporosis on the basis of the increase or decrease of the IPC should not be done. This is promoted and the lack of regional databases regional standards IPC.

The prior art is unknown, and the applicant by studies revealed that the severity of osteoporosis, its dynamics and determine the effectiveness of the drug is necessary to consider qualitative criteria: morphology osteoporotic manifestations, namely by definition cavitary mass in trabecular departments bones. Excluding (cavities) morphometric manifestations of osteoporosis determining the severity of the disease and the effectiveness of a drug to do difficult or impossible.

The objective of the claimed invention is an objective assessment of the effectiveness of the drug (s) (osteoprotegerin) and the definition of cavitary mass in trabecular departments bones. It is proposed to improve diagnostic who is agnosti computer osteometric by identifying cavitary mass in osteoporosis and to determine the severity of the disease not only mineral density, but the presence of cavities in the trabecular departments bones.

This task is solved by that in a method for the diagnosis of osteoporosis, including laboratory, histological, radiological methods of examination (standard x-rays) and the determination of bone mineral density interabsorbtion method on osteometric, which introduces an additional diagnostic criterion is the definition of cavity formations by special customize their definition cavitary mass in trabecular departments bones interabsorbtion method in the diagnosis of osteoporosis on osteometric around the investigated limb bones of the hands and feet in a special incubator distilled water is introduced.

Here are some osteometrical studies we have observed patients who have the diagnosis of osteoporosis according to the results of determination of the IPC was not raised (see example 1).

Example 1. Patient A. the Reduction of BMD in T-skore from-2.1 and -2,3 WITH. This is according to the who classification is laid down in the diagnosis of osteopenia 3 degrees. However, this patient in the trabecular part of the elbow bone is determined by the cavity 2×4 mm, This is the main of the 2 indicators is a sign of osteoporosis (1).

Example 2. The patient B. BMD (bone mineral density) corresponds to osteopenia 2 degree (-1,8). However, in trabecular departments bones are castke with pronounced demineralization, what we call "cavity", that is, it is not osteopenia and osteoporosis (2).

The prior art is unknown, which is the identification of cavitary lesions in the bones of the negative dynamics of the values of bone mineral density is important in the diagnosis of osteoporosis. However, all modern osteometry "see" cavity, as configured only on the definition of the IPC, which is a disadvantage of such devices. To see cavitary education in the bones, you must create osteometry subject to certain conditions. We found that, around the studied bones of the extremities (hands, feet) in a special incubator necessary distilled water. Then such osteometry type DTX - 100 allows simultaneous determination of the IPC and the cavity. If instead of distilled water around the studied air cavity is not defined. Our experience and new knowledge about osteoporosis show that devices of this type are now very important, as they determine additional 2 parameters: the cavity and excess accumulation of salts in the soft tissues. For other types of osteometric (type DTX-200), so that they could "see" cavity, need a special configuration of the apparatus, which was made by the authors in the reference data obtained with the apparatus of DTH-100.

In some cases, when working on these "seers" of the apparatus showing the deposits of the IPC is reduced, for example, up to 2.4 WITH (osteopenia), however, the identification of cavitary lesions in bones such patients it is necessary to set the diagnosis of osteoporosis. Especially in cases when the dynamics monitoring these cavities increase or history there are instructions on broken bones.

Therefore, to determine the effectiveness of the drug in the treatment of osteoporosis on the phones of the new generation type DTX-200 (not seeing cavity) only one indicator of the IPC may be erroneous.

For example, the patient E. was appointed calcium D3 Nycomed. The example 2 shows the results of therapy after 12 months. While salinity increased from - 3.4 to - 1,9 (from osteoporosis to osteopenia 2 degrees), and abdominal education increased. So if you do the evaluation of the effectiveness of the treatment apparatus DTX-200 IPC, it can be viewed as a positive result and, consequently, about the effectiveness of this medication (calcium Dz Nycomed") and the possibility of drug or reducing the dose, shorter courses of treatment, etc.

If, however, assess the dynamics of the disease and the effectiveness of the drug Calcium Dz Nycomed in the treatment of osteoporosis apparatus DTX 100 (or specially configured DTX-200, which "sees" the cavity and simultaneously determines bone mineral density), then the conclusion in such readings will be absolutely other is im - the severity of osteoporosis by increasing the size of cavity formations, on the background of a slight improvement in bone mineralization. The drug Calcium Dz Nycomed ineffective. You need to change your medication to another due to an increase in cavities, i.e. there is no effect in the restoration of bone structure.

Example 3. Patient E. postmenopausal Osteoporosis. Abdominal education in metatithemi (trabecular) sections of bone, BMD T-score of 3.4 (Fig.3).

The purpose of this invention is to develop a method of improving the diagnosis of osteoporosis and objective assessment of the effectiveness of the drug (s) (osteoprotegerin). We propose the following method:

In the test group and the comparison group include homogeneous group of patients by age and gender.

1. The selection of patients to determine the effectiveness of the drug: only by the presence of cavitary mass;

2. Patients with IPC from -2,5 WITH less.

3. Patients only women with primary osteoporosis (for example, postmenopausal). Or only men with primary osteoporosis.

4. Excluded patients with secondary osteoporosis under different system, endocrine diseases, pathologies, etc.

5. Patients (the test participants) issue of voluntary consent to the experiment.

6. Patients do not need to know all of the applicable drug (blind experience).

7. X-ray absorption osteometry is carried out in both groups before treatment and every three to four months.

8. The results are subjected to the ordinary statistical processing. As a reference (control) can be selected any drug, preferably the most purchased.

The method of determining the effectiveness of the drug or set of drugs for the treatment of osteoporosis, including diagnosis of osteoporosis and to monitor it interabsorbtion method on osteometry, characterized in that the diagnostic criteria of osteoporosis accept the presence of cavitary mass in trabecular departments bones, on the dynamics of the closure which is judged on the effectiveness of the drug or drugs.



 

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