Trial Outcomes & Findings for Comparative Effects of Moxonidine on Bone Metabolism, Vascular and Cellular Aging in Hypertensive Postmenopausal Women (NCT NCT02355821)
NCT ID: NCT02355821
Last Updated: 2021-09-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
baseline (Visit 1) and 12 months (Visit 4)
Results posted on
2021-09-01
Participant Flow
Participant milestones
| Measure |
Moxonidine
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effects of Moxonidine on Bone Metabolism, Vascular and Cellular Aging in Hypertensive Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Continuous
|
62.96 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
62 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
57 participants
n=5 Participants
|
57 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Bone resorption marker (collagen type 1 C-telopeptide)
|
0.4 ng/ml
n=5 Participants
|
0.4 ng/ml
n=7 Participants
|
0.4 ng/ml
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (Visit 1) and 12 months (Visit 4)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
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Collagen Type 1 C-telopeptide
Baseline
|
0.4 ng/ml
Interval 0.3 to 0.5
|
0.4 ng/ml
Interval 0.3 to 0.6
|
|
Collagen Type 1 C-telopeptide
12 months
|
0.3 ng/ml
Interval 0.2 to 0.4
|
0.4 ng/ml
Interval 0.3 to 0.5
|
SECONDARY outcome
Timeframe: baseline (Visit 1) and 12 months (Visit 4)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.
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Osteocalcin
Baseline
|
18.2 ng/ml
Interval 12.4 to 21.9
|
19.4 ng/ml
Interval 12.4 to 26.2
|
|
Osteocalcin
12 months
|
19.6 ng/ml
Interval 15.4 to 23.5
|
18.7 ng/ml
Interval 12.8 to 22.79
|
SECONDARY outcome
Timeframe: baseline (Visit 1) and 12 months (Visit 4)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
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL).
Baseline
|
0.109 pmol/ml
Interval 0.06 to 0.18
|
0.133 pmol/ml
Interval 0.06 to 0.182
|
|
Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL).
12 month
|
0.09 pmol/ml
Interval 0.05 to 0.17
|
0.111 pmol/ml
Interval 0.07 to 0.163
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Total hip BMD
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
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Bone Mineral Density (BMD) Using Control Dual-energy X-ray Absorptiometry
Baseline
|
-1.0 g/cm2
Interval -1.7 to -0.2
|
-0.55 g/cm2
Interval -1.3 to -0.2
|
|
Bone Mineral Density (BMD) Using Control Dual-energy X-ray Absorptiometry
12 months
|
-0.6 g/cm2
Interval -0.9 to -0.1
|
-1.2 g/cm2
Interval -1.9 to -0.75
|
SECONDARY outcome
Timeframe: baseline (Visit 1) and 12 months (Visit 4)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.
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Telomerase Activity
Baseline
|
0.87 arbitrary units
Interval 0.16 to 1.18
|
0.89 arbitrary units
Interval 0.16 to 1.15
|
|
Telomerase Activity
12 months
|
1.15 arbitrary units
Interval 0.74 to 1.59
|
0.64 arbitrary units
Interval 0.46 to 1.01
|
SECONDARY outcome
Timeframe: baseline (Visit 1) and 12 months (Visit 4)Changes in mean pulse wave velocity (PWV) at final visit versus baseline level and in comparison between the groups
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Pulse Wave Velocity (PWV)
Baseline
|
10.35 m/s
Standard Deviation 2.56
|
10.36 m/s
Standard Deviation 2.47
|
|
Pulse Wave Velocity (PWV)
12 months
|
10.05 m/s
Standard Deviation 2.29
|
11.26 m/s
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: baseline (Visit 1) and 12 months (Visit 4)Changes in mean intima-media thickness (IMT) at final visit in comparison between the groups.
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Intima-media Thickness (IMT)
Baseline
|
0.98 mm
Standard Deviation 0.17
|
0.98 mm
Standard Deviation 0.15
|
|
Intima-media Thickness (IMT)
12 months
|
0.77 mm
Standard Deviation 0.14
|
0.88 mm
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: baseline (Visit 1) and 12 months (Visit 4)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.
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
THe Number (Percentage) of the Treatment Responders
|
55 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: baseline (Visit 1) and 12 months (Visit 4)Number of Participants with Adverse Events (AE)
Outcome measures
| Measure |
Moxonidine
n=57 Participants
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 Participants
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
Number of Participants With Adverse Events (AE)
|
3 Participants
|
3 Participants
|
Adverse Events
Moxonidine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bisoprolol
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moxonidine
n=57 participants at risk
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Moxonidine: 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
|
Bisoprolol
n=57 participants at risk
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Bisoprolol: 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
|
|---|---|---|
|
General disorders
headache
|
3.5%
2/57 • Number of events 2 • baseline (Visit 1) and 12 months (Visit 4)
|
1.8%
1/57 • Number of events 1 • baseline (Visit 1) and 12 months (Visit 4)
|
|
General disorders
cough
|
0.00%
0/57 • baseline (Visit 1) and 12 months (Visit 4)
|
3.5%
2/57 • Number of events 2 • baseline (Visit 1) and 12 months (Visit 4)
|
|
General disorders
Dry mouth
|
1.8%
1/57 • Number of events 1 • baseline (Visit 1) and 12 months (Visit 4)
|
0.00%
0/57 • baseline (Visit 1) and 12 months (Visit 4)
|
Additional Information
Ekaterina Dudinskaya, head of age-related metabolic and endocrine disorders laboratory
RGNKC
Phone: +79031914690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place