Osteopenia MedDRA version: 24.0 Level: LLT Classification code 10021059 Term: Hypophosphatemia System Organ Class: 100000004861 MedDRA version: 20.1 Level: LLT Classification code 10021689 Term: Increased thirst System Organ Class: 100000004867 MedDRA version: 20.0 Level: PT Classification code 10016766 Term: Flatulence System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 21.1 Level: LLT Classification code 10081649 Term: Rebound gastric hypersecretion System Organ Class
Conditions
Sponsors
BIOMIN, a. s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient must not participate in the trial if she does not meet all of the inclusion criteria below 1. The patient must sign an informed consent form before performing any examination for the purpose of the trial. 2. The patient must be mentally competent / self-able, able to read, understand and sign informed consent. 3. Age: 60 and older. 4. Diagnosed osteopenia - T-score (-1 SD to -2.5 SD) in the L1-4 area of the lumbar spine and / or total hip and / or femoral neck. 5. Without prior specific treatment for osteoporosis. 6. At present (1 month before the screening examination) does not use calcium resp. vitamin D3 (or active forms of vitamin D3) or K2 in the form of drugs or nutritional supplements. 7. The patient had a densitometric examination confirming osteopenia at most 30 days before the Screening Visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: A patient may not take part in the trial if she meets at least one of the exclusion criteria below 1. The patient refused to sign the informed consent or is not independent or capable of reading, understanding or signing informed consent. 2. The patient is less than 60 years old. 3. The patient is taking medicines for osteoporosis. 4. A patient with a vertebral body fracture. 5. Gender: male 6. Diagnosed diseases leading to secondary osteoporosis. 7. Patient with a history of calcium allergy, chronic diarrhea, heart disease (NYHA III, IV), kidney stones, kidney disease (CKD 3 and more), sarcoidosis, absorption disorders, other serious diseases. 8. A patient with a clinically significantly elevated parathyroid hormone level at the last blood biochemical examination. 9. A patient with a clinically significantly elevated blood calcium level at the last blood biochemical examination. 10. Patient with calcium above 4 mg / kg / day. 11. Patient with severe vitamin D deficiency (= 10ng / ml, = 25nmol / l). 12. The patient is taking at least one of the following drugs: cardioglycosides, coumarin drugs (eg Warfarin), anticoagulants, phenylbutazone, phenytoin, chlorpromazine, calcitonin, corticosteroids, phytic acid, nalidixic acid, nicardipine, nimodipicillinicillin, oxyphenoic acid, pentobarbital, iron preparations, tetracycline antibiotics (especially doxycycline), vitamin A, active form of vitamin D (eg Alfacalcidiol, Rocaltrol), vitamin B7 (Biotin). 13. Patient with hypersensitivity to the active substance or to any of the excipients of the monitored treatment (calcium, magnesium, phosphorus and other trace elements). 14. The patient is participating in different clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of treatment efficacy by comparing the percentage change in bone density and selected parameters of bone quality and bone metabolism from the "Screening" day to the "End of Study" day between two groups of patients (with or without vitamin K2 supplementation);Secondary Objective: • Comparison of the percentage change of selected new markers of bone turnover (sclerostin, DKK-1) and sarcopenia parameters from the day of "Screening" to the day of "End of Study" between two groups of patients (with or without vitamin K2 supplementation) • Comparison of frequency and type of adverse reactions (tolerability), aortic calcifications (safety) and clinical fractures between two groups of patients • Comparison of adherence to therapy between two groups of patients;Primary end point(s): Stabilized bone density;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Preventing the formation of vertebral body fractures;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Czechia, Czech Republic, Slovakia
Contacts
Public ContactAdam Szabo
BIOMIN, a. s.
Outcome results
None listed