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Trial record 58 of 123 for:    hypertension "vitamin d"

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

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ClinicalTrials.gov Identifier: NCT02355821
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
National Research Center for Preventive Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Osteopenia Arterial Hypertension Drug: Moxonidine Drug: Bisoprolol Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparative Effects of Moxonidine and Bisoprolol on Bone Metabolism, Vascular and Cellular Markers of Aging, Blood Pressure in Hypertensive Postmenopausal Women (COMPASS)
Study Start Date : April 2015
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moxonidine
0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID
Drug: 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
Other Name: Physiotens

Active Comparator: Bisoprolol
5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID
Drug: 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




Primary Outcome Measures :
  1. collagen type 1 C-telopeptide [ Time Frame: 12 months ]
    Changes in mean values 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


Secondary Outcome Measures :
  1. osteocalcin [ Time Frame: 12 months ]
    Changes in mean 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.

  2. receptor activator of nuclear factor kappa-B ligand (RANKL). [ Time Frame: 12 months ]
    Changes in mean values of the receptor activator of nuclear factor kappa-B ligand (RANKL) at final visit versus baseline level in comparison between the groups

  3. BMD using control dual-energy X-ray absorptiometry [ Time Frame: 12 months ]
    Changes in mean values of BMD at final visit versus baseline level using control dual-energy X-ray absorptiometry and in comparison between the groups

  4. telomerase activity [ Time Frame: 12 months ]
    Changes in mean telomerase activity at final visit versus baseline level in comparison between the groups

  5. pulse wave velocity (PWV) [ Time Frame: 12 months ]
    Changes in mean pulse wave velocity (PWV) at final visit versus baseline level and in comparison between the groups

  6. intima-media thickness (IMT) [ Time Frame: 12 months ]
    TChanges in mean intima-media thickness (IMT) at final visit in comparison between the groups.

  7. Proportion of the treatment responders [ Time Frame: 12 months ]
    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.

  8. Adverse events (AEs) [ Time Frame: 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

    -

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. SistBP ≥180 mm Hg and/or DiastBP ≥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

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355821


Locations
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Russian Federation
National Research Center for Preventive Medicine
Moscow, Russian Federation, 101000
Sponsors and Collaborators
National Research Center for Preventive Medicine
Investigators
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Principal Investigator: Olga N Tkacheva, Professor tkacheva@rambler.ru

Additional Information:
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Responsible Party: National Research Center for Preventive Medicine
ClinicalTrials.gov Identifier: NCT02355821     History of Changes
Other Study ID Numbers: MOXOC001
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Research Center for Preventive Medicine:
cellular aging
vascular aging
bone metabolism
collagen type 1 C-telopeptide
nuclear factor kappa-B ligand (RANKL)
pulse wave velocity
telomerase activity

Additional relevant MeSH terms:
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Hypertension
Bone Diseases, Metabolic
Vascular Diseases
Cardiovascular Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Carbonate
Bisoprolol
Moxonidine
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents