Preparation for the Prophylaxis and Treatment of Atypical Osteoporosis

Abstract

A preparation for preventing and treating atypical osteoporosis with normal or increased bone tissue mineralization with the presence of cavities in trabecular bone sections, and conditions close to same, comprises between 10 mg and 1000 mg of drone brood and between 50 IU and 100,000 IU of vitamin D or vitamins of this group and/or the active metabolites in a daily dose. The preparation can be provided in powder, tablet or capsule form. It facilitates the redistribution of calcium in the body, reducing mineralization in soft tissues, vessels and other organs, as well as filling cavities in trabecular bone.

Claims

1. A preparation for preventing and treating atypical osteoporosis with normal or increased bone tissue mineralization with the presence of cavities in trabecular bone sections, and conditions close thereto involving excess mass and metabolic syndrome, the preparation comprising in a daily dose between 10 mg and 1000 mg of drone brood and between 50 IU and 100,000 of vitamin D or vitamins of group D and/or the active metabolites thereof.

2. The preparation according to claim 1, wherein it is provided in powder, tablet or capsule form.

Description

SUMMARY OF THE INVENTION

[0015] The object of the claimed invention consists in creating an agent that can facilitate redistribution of calcium in the body: reducing mineralization in soft tissues, vessels and other organs, and being instrumental in the filling of trabecular bone cavities.

[0016] This object is achieved by providing a preparation for the prevention and treatment of atypical osteoporosis with normal or increased bone tissue mineralization with the presence of cavities in trabecular bone sections (and conditions close thereto involving excess mass and metabolic syndrome), which preparation comprises between 10 mg and 1000 mg of drone brood and between 50 IU and 100,000 IU of vitamin D or vitamins of group D and/or the active metabolites thereof and the preparation is provided in powder, tablet or capsule form.

[0017] The preparation was created and tested on volunteers, the ratio of ingredients being between 50 IU and 100,000 IU per day of vitamin D or vitamins of this group (and/or the active metabolites thereof); and between 10 mg and 1000 mg per day of drone brood. The claimed agent can be provided in powder, tablet or capsule form.

[0018] Vitamin D is included because although drone brood is saturated with vitamins, vitamin D3 being among others, but in non-replenishing, small doses. Therefore, the concentration thereof is insufficient for treating osteoporosis.

[0019] Drone brood has to be introduced as a donor of the following sex hormones which have a positive effect on bone mineralization: estradiol, progesterone and testosterone.

[0020] The range of the ingredients in the claimed preparation is determined by the patient demographics: age, eating habits, lifestyle, race, country of habitation, gender, and genetic and previous diseases. A doctor assessing these criteria selects the specific proportion of the ingredients and adjusts it based on cavity closure dynamics.

[0021] An explanation of the range limits:

[0022] 1) Between 50 IU and 100,000 IU per day of vitamin or vitamins of group D (and/or active metabolites thereof), the lower limit being selected based on effectiveness, the upper limitbased on toxicity.

[0023] 2) Between 10 mg to 1000 mg per day of drone brood, the lower limit being selected based on the effectiveness, the upper limitbased on the feasibility of use in terms of the ratio of effectiveness/price rise of the product.

[0024] The studies have established that using the claimed preparation strengthens the mechanism of the uniform restoration of bone mineral density, the use of drone brood in combination with vitamin D additionally aims at enhancing the remodeling of damaged bone tissue sections and bone tissue retention by maintaining androgen levels.

[0025] The combined use of vitamin D with drone brood makes it possible to achieve the greatest effectiveness in osteoporosis therapy in patients with hypercalcemic conditions and reduce the frequency of such adverse side effects as calcified deposits and stones forming in the kidneys and in other organs.

[0026] Although the components of the claimed preparation have, been known in folk and traditional medicine, the combination thereof in one product is not known, and it is just uncovered synergistic effect that makes it possible to solve the problem of balanced bone mineralization in both trabecular bone sections and cortical bone sections and achieve the object of the invention, eliminating or reducing the imbalance in the mineralization of various bone tissue sections.

[0027] Examples of closing cavities using the homogenate of drone brood and vitamin D3 in patients with hypermineralization:

[0028] Example No. 1: Patient FAD, female, 64, with postmenopausal osteoporosis. The patient was taking for a year Calcium D.sub.3 Forte made by NIKOMED. She has been diagnosed with hypermineralization, salt deposits in her soft tissues. Despite this condition, the patient has cavities. She was prescribed treatment with the claimed agent in the form of a powder mixture: 1000 mg of drone brood+100 IU of vitamin D.sub.3 per day. The picture taken at the beginning of treatment clearly showed salt deposits in soft tissues, which indicates hypermineralization. After nine months of treatment, it could be seen that the claimed agent reduced salt deposits and closed the cavities. In other words, calcium was redistributed within the body.

[0029] Example No. 2: Patient Z., female, 66, with postmenopausal osteoporosis. The patient was taking for nine months Calcium D.sub.3 Forte made by NIKOMED. She has been diagnosed with hypermineralization, salt deposits in her soft tissues. Despite this condition, the patient has cavities. She was prescribed treatment with the claimed agent in a composition in the form of a powder mixture: 500 mg of drone brood+2500 IU of vitamin D3 per day. After six-month treatment, the cavities were reduced and the salt deposits in the soft tissues disappeared.

[0030] Example No. 3: Patient Z1, female, 70, with postmenopausal osteoporosis. The patient was taking for 12 months Calcium D.sub.3 Forte made by NIKOMED. She has been diagnosed with hypermineralization, salt deposits in her soft tissues. Despite this condition, the patient has large cavities. She was prescribed treatment with the claimed agent in a composition in the form of a powder mixture: 500 mg of drone brood+100,000 IU of vitamin D2 per day for six months. The cavities closed, but the salt deposits in the soft tissues did not completely disappear, which shows that too large dose of vitamin D2 for this patient was used.

[0031] Regarding the range for using vitamin D and the active metabolites thereof, it should be noted that various forms of vitamin D have various degrees of therapeutic activity. Thus, vitamin D.sub.2 is weaker than vitamin D.sub.3, and therefore a greater amount of D.sub.2 is required in comparison to vitamin D.sub.3. The same is true regarding vitamin D metabolites.

[0032] Example No. 4, to show ineffectiveness of the claimed agent where its dosage is lower than the low limit. The patient D., female, 60, with postmenopausal osteoporosis. The patient was taking Calcium D.sub.3 Forte, made by NIKOMED, for six months. She has been diagnosed with hypermineralizationsalt deposits in her soft tissues. No cavities yet. She was prescribed treatment with the claimed agent in a composition in the form of a powder mixture: 9 mg of drone brood and 40 IU of vitamin D.sub.2 per day for six months. As a result, there were no significant changes, the bone mineral density has been reduced, the mineral deposits have also proportionally reduced.

[0033] When prescribing the claimed agent, the doctor chooses the dosage of the ingredients thereof individually, based on the patient disease status. The condition of the patient is recommended to evaluate every 6-9 months using densitometry apparatuses to measure cavities and adjusting the specific composition of the claimed agent.