N/A
Completed N=114
Comparative Effects of Moxonidine on Bone Metabolism, Vascular and Cellular Aging in Hypertensive Postmenopausal Women
Source: ClinicalTrials.gov NCT02355821 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Collagen Type 1 C-telopeptide — 0.4; 0.4; 0.3; 0.4 ng/ml
Summary
This study evaluates the effect of moxonidine versus bisoprolol on collagen type 1 C-telopeptide in postmenopausal female patients with arterial hypertension and osteopenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Collagen Type 1 C-telopeptide |
0.4; 0.4; 0.3; 0.4 | — |
| SECONDARY Osteocalcin |
18.2; 19.4; 19.6; 18.7 | — |
| SECONDARY Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). |
0.109; 0.133; 0.09; 0.111 | — |
| SECONDARY Bone Mineral Density (BMD) Using Control Dual-energy X-ray Absorptiometry |
-1.0; -0.55; -0.6; -1.2 | — |
| SECONDARY Telomerase Activity |
0.87; 0.89; 1.15; 0.64 | — |
| SECONDARY Pulse Wave Velocity (PWV) |
10.35; 10.36; 10.05; 11.26 | — |
| SECONDARY Intima-media Thickness (IMT) |
0.98; 0.98; 0.77; 0.88 | — |
| SECONDARY THe Number (Percentage) of the Treatment Responders |
55; 53 | — |
| SECONDARY Number of Participants With Adverse Events (AE) |
3; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Female with age 45 years and older.
- Postmenopausal (absence of menstrual periods for a minimum of 12 months) at the moment of Informed Consent sign.
- Arterial hypertension grade I / II per ESH/ESC 2013 guidelines (diastolic pressure ≥ 90 and <110 mm Hg, systolic pressure ≥140 and <180 mm Hg).
- Not achieving BP targets <140/90 mmHg either during antihypertensive therapy or naive.
- Absence of moxonidine or bisoprolol treatment at least 6 months before the study
- Osteopenia of lumbar spine and/or proximal part of the femur (osteoporosis T-score from -1 to -2.5 standard deviations [SD]) by X-Ray densitometry.
- Signed Informed Consent for participation in the study
-
Exclusion Criteria
- Hypersensitivity to moxonidine, bisoprolol or any other ingredient of the respective formulations
- Any Contraindications for moxonidine, bisoprolol
- Osteoporosis (Т-score below - 2.5 SD).
- Primary or secondary hyperparathyroidism.
- Paget's disease of bones.
- History of low traumatic bone fractures.
- Malabsorption syndrome.
- History of gastro-intestinal surgery.
- Severe disturbance of peripheral circulation.
- Raynaud's disease.
- Symptomatic (secondary) hypertension (caused by any primary internal diseases)
- Morbid obesity (BMI over 40 kg/m2).
- Symptoms of estrogen deficiency such as hot flushes, nights sweat, vaginal dryness
- Administration of any hormone-replacement therapy (HRT) or intake of isoflavones
- Secondary hypogonadism.
- Sistolic BP ≥180 mm Hg and/or Diastolic BP ≥110 mm Hg.
- Clinical presentations of cardiovascular disease: coronary heart disease (CHD), history of stroke, transient ischemic attack (TIA), Charcot's syndrome.
- Severe heart failure.
- Hemodynamically significant congenital heart disease.
- Heart rhythm disorders which require permanent use of any antiarrhythmic medications (including β-adrenoblockers and calcium antagonists).
- Diabetes mellitus of any genesis.
- Severe liver failure.
- Severe kidney failure including patients on dialysis
- Thyroid diseases accompanied by functional disorders (thyrotoxicosis or uncompensated hypothyroidism).
- Alcohol and drug abuse.
- Patients with oncological diseases diagnosed within 5 years before IC execution.
- Inability of the patient to comprehend the essence of the program and to provide his/her consent for participation in the program.
- Patients with any condition, which in the opinion of the Investigator makes the patient unsuitable for inclusion based on clinical judgment.
- Corticosteroid therapy
- Participation in any other clinical study during the whole course of this investigation including participation in a study within 30 days prior to providing the informed consent for this trial
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Data sourced from ClinicalTrials.gov (NCT02355821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.