This study evaluates the effect of moxonidine versus bisoprolol on collagen type 1 C-telopeptide in postmenopausal female patients with arterial hypertension and osteopenia.
Several experimental studies have demonstrated that moxonidine may lower the activity of Na+- independent Cl-/bicarbonate exchanger (anion exchanger, AE) which plays an essential role in viability of osteoclasts that are crucial for bone resorption. The suppression of AE proteins activity has been proven to inhibit osteoclast activity and reduce bone resorption whereas the moxonidine molecule is known to reduce the AE protein activity. Therefore, the results of experimental studies have shown the ability of moxonidine to inhibit bone resorption through its effect on the osteoclast activity. Published data contain information on positive effects of beta-blockers on the bone tissue condition. There are data which clearly demonstrate a positive effect of beta-blockers on bone mass. The proposed trial is a comprehensive study of moxonidine effects on processes of cellular and vascular aging as well as bone metabolism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
114
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID Other Names:perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID Other Names: perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D
National Research Center for Preventive Medicine
Moscow, Russia
Collagen Type 1 C-telopeptide
Changes in Median (Inter-Quartile Range) of the bone resorption marker (collagen type 1 C-telopeptide) at the end of the study from the baseline are evaluated in comparison between the groups
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Osteocalcin
Changes in Median (Inter-Quartile Range) values of the bone synthesis marker (osteocalcin) at the end of the study (V4) from the baseline (V1) and to compare the values between the groups.
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL).
Changes in Median (Inter-Quartile Range) values of the receptor activator of nuclear factor kappa-B ligand (RANKL) at final visit versus baseline level in comparison between the groups
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Bone Mineral Density (BMD) Using Control Dual-energy X-ray Absorptiometry
Changes in Median (Inter-Quartile Range) values of Bone mineral density (BMD) at final visit versus baseline level using control dual-energy X-ray absorptiometry and in comparison between the groups
Time frame: 12 months
Telomerase Activity
Changes in Median (Inter-Quartile Range) telomerase activity at final visit versus baseline level in comparison between the groups Telomerase activity is measured in arbitrary units. Currently, there are no established reference values for telomerase activity in the world. Its activity is considered high or low in relation to the median.
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Pulse Wave Velocity (PWV)
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Changes in mean pulse wave velocity (PWV) at final visit versus baseline level and in comparison between the groups
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Intima-media Thickness (IMT)
Changes in mean intima-media thickness (IMT) at final visit in comparison between the groups.
Time frame: baseline (Visit 1) and 12 months (Visit 4)
THe Number (Percentage) of the Treatment Responders
Proportion of the treatment responders (defined as the proportion (%) of patients who achieved target blood pressure \<140/90 mmHg) after 8 and 48 weeks of the investigated treatment (V2, V3 and V4) and to compare the values between the groups.
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Number of Participants With Adverse Events (AE)
Number of Participants with Adverse Events (AE)
Time frame: baseline (Visit 1) and 12 months (Visit 4)