OsteopeniaCOMPASSNCT02355821
Comparative Effects of Moxonidine on Bone Metabolism, Vascular and Cellular Aging in Hypertensive Postmenopausal Women
A study testing Moxonidine and Bisoprolol in people with Osteopenia and Arterial Hypertension, run by National Research Center for Preventive Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteopenia, Arterial Hypertension
- What is being tested?
- Moxonidine and Bisoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteRussia
- Study dates
- Apr 2015to 10 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
- 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.
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- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Moxonidine and Bisoprolol on Bone Metabolism, Vascular and Cellular Markers of Aging, Blood Pressure in Hypertensive Postmenopausal Women (COMPASS)
This study evaluates the effect of moxonidine versus bisoprolol on collagen type 1 C-telopeptide in postmenopausal female patients with arterial hypertension and osteopenia.
Read the 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.
- Conditions
- Osteopenia, Arterial Hypertension
- Being tested
- Moxonidine, Bisoprolol
- Keywords
- cellular aging, vascular aging, bone metabolism, collagen type 1 C-telopeptide, nuclear factor kappa-B ligand (RANKL), pulse wave velocity, telomerase activity
- Medical subject headings
- Bone Diseases, Metabolic, Hypertension, Osteopetrosis, mild autosomal recessive form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxonidineDrug
Also called Physiotens
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
BisoprololDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Moxonidine | Experimental | 0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID Receives: Drug: Moxonidine |
| Bisoprolol | Active comparator | 5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID Receives: Drug: Bisoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline (Visit 1) and 12 months (Visit 4)
Secondary outcomes (8)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline (Visit 1) and 12 months (Visit 4)
Pulse Wave Velocity (PWV)
Changes in mean pulse wave velocity (PWV) at final visit versus baseline level and in comparison between the groups
Measured: 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.
Measured: 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.
Measured: baseline (Visit 1) and 12 months (Visit 4)
Number of Participants With Adverse Events (AE)
Number of Participants with Adverse Events (AE)
Measured: baseline (Visit 1) and 12 months (Visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startApr 2015
- Primary completion15 Jun 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olga N Tkacheva, Professor, Principal investigator, tkacheva@rambler.ru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355821
- Sponsor's protocol ID
- MOXOC001
- Acronym
- COMPASS
- Status last verified
- Aug 2021
- First submitted
- 13 Jan 2015
- Last updated
- 1 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Moxonidine and Bisoprolol on Bone Metabolism, Vascular and Cellular Markers of Aging, Blood Pressure in Hypertensive Postmenopausal Women (COMPASS)
- ClinicalTrials.gov ID
- NCT02355821
- Acronym / sponsor ID
- COMPASS / MOXOC001
- Conditions
- Osteopenia, Arterial Hypertension
- Keywords
- cellular aging, vascular aging, bone metabolism, collagen type 1 C-telopeptide, nuclear factor kappa-B ligand (RANKL), pulse wave velocity, telomerase activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Study start
- Apr 2015
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Posted 1 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of moxonidine versus bisoprolol on collagen type 1 C-telopeptide in postmenopausal female patients with arterial hypertension and osteopenia.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxonidine | Experimental | Drug: Moxonidine0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID |
| Bisoprolol | Active comparator | Drug: Bisoprolol5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxonidineAlso: Physiotens0.4 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 | Drug | Moxonidine |
| Bisoprolol5 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 | Drug | Bisoprolol |
Primary outcome
Collagen Type 1 C-telopeptide
Time frame: 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
8 secondary outcomes
Osteocalcin
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL).
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Bone Mineral Density (BMD) Using Control Dual-energy X-ray Absorptiometry
Time frame: 12 months
Telomerase Activity
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Pulse Wave Velocity (PWV)
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Intima-media Thickness (IMT)
Time frame: baseline (Visit 1) and 12 months (Visit 4)
THe Number (Percentage) of the Treatment Responders
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Number of Participants With Adverse Events (AE)
Time frame: baseline (Visit 1) and 12 months (Visit 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga N Tkacheva, Professor principal investigator
tkacheva@rambler.ru
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxonidine and Bisoprolol in people with Osteopenia and Arterial Hypertension, run by National Research Center for Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collagen Type 1 C-telopeptide (time frame: baseline (Visit 1) and 12 months (Visit 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.