Comparative Effects of Moxonidine on Bone Metabolism, Vascular and Cellular Aging in Hypertensive Postmenopausal Women

• Status: Completed
• Trial end date: 2018-07-10
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Research Center for Preventive Medicine
• Treatments: Bisoprolol; Calcium Carbonate; Moxonidine

Criteria

Inclusion Criteria:

1. Female with age 45 years and older.

2. Postmenopausal (absence of menstrual periods for a minimum of 12 months) at the moment of Informed Consent sign.

3. Arterial hypertension grade I / II per ESH/ESC 2013 guidelines (diastolic pressure ≥ 90 and <110 mm Hg, systolic pressure ≥140 and <180 mm Hg).

4. Not achieving BP targets <140/90 mmHg either during antihypertensive therapy or naive.

5. Absence of moxonidine or bisoprolol treatment at least 6 months before the study

6. 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.

7. Signed Informed Consent for participation in the study

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Exclusion Criteria:

1. Hypersensitivity to moxonidine, bisoprolol or any other ingredient of the respective formulations

2. Any Contraindications for moxonidine, bisoprolol

3. Osteoporosis (Т-score below - 2.5 SD).

4. Primary or secondary hyperparathyroidism.

5. Paget's disease of bones.

6. History of low traumatic bone fractures.

7. Malabsorption syndrome.

8. History of gastro-intestinal surgery.

9. Severe disturbance of peripheral circulation.

10. Raynaud's disease.

11. Symptomatic (secondary) hypertension (caused by any primary internal diseases)

12. Morbid obesity (BMI over 40 kg/m2).

13. Symptoms of estrogen deficiency such as hot flushes, nights sweat, vaginal dryness

14. Administration of any hormone-replacement therapy (HRT) or intake of isoflavones

15. Secondary hypogonadism.

16. Sistolic BP ≥180 mm Hg and/or Diastolic BP ≥110 mm Hg.

17. Clinical presentations of cardiovascular disease: coronary heart disease (CHD), history of stroke, transient ischemic attack (TIA), Charcot's syndrome.

18. Severe heart failure.

19. Hemodynamically significant congenital heart disease.

20. Heart rhythm disorders which require permanent use of any antiarrhythmic medications (including β-adrenoblockers and calcium antagonists).

21. Diabetes mellitus of any genesis.

22. Severe liver failure.

23. Severe kidney failure including patients on dialysis

24. Thyroid diseases accompanied by functional disorders (thyrotoxicosis or uncompensated hypothyroidism).

25. Alcohol and drug abuse.

26. Patients with oncological diseases diagnosed within 5 years before IC execution.

27. Inability of the patient to comprehend the essence of the program and to provide his/her consent for participation in the program.

28. Patients with any condition, which in the opinion of the Investigator makes the patient unsuitable for inclusion based on clinical judgment.

29. Corticosteroid therapy

30. 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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