NCT02355821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 1, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

3.2 years

First QC Date

January 13, 2015

Results QC Date

June 17, 2020

Last Update Submit

August 5, 2021

Conditions

OsteopeniaArterial Hypertension

Keywords

cellular agingvascular agingbone metabolismcollagen type 1 C-telopeptidenuclear factor kappa-B ligand (RANKL)pulse wave velocitytelomerase activity

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline (Visit 1) and 12 months (Visit 4)

Secondary Outcomes (8)

  • Osteocalcin

    baseline (Visit 1) and 12 months (Visit 4)

  • Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL).

    baseline (Visit 1) and 12 months (Visit 4)

  • Bone Mineral Density (BMD) Using Control Dual-energy X-ray Absorptiometry

    12 months

  • Telomerase Activity

    baseline (Visit 1) and 12 months (Visit 4)

  • Pulse Wave Velocity (PWV)

    baseline (Visit 1) and 12 months (Visit 4)

  • +3 more secondary outcomes

Study Arms (2)

Moxonidine

EXPERIMENTAL

0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID

Drug: Moxonidine

Bisoprolol

ACTIVE COMPARATOR

5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID

Drug: Bisoprolol

Interventions

MoxonidineDRUG

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

Also known as: Physiotens
Moxonidine
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

Bisoprolol

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Center for Preventive Medicine

Moscow, 101000, Russia

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicHypertensionOsteopetrosis, mild autosomal recessive form

Interventions

moxonidineBisoprolol

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Results Point of Contact

Title
Ekaterina Dudinskaya, head of age-related metabolic and endocrine disorders laboratory
Organization
RGNKC
katharina.gin@gmail.com
+79031914690

Study Officials

  • Olga N Tkacheva, Professor

    tkacheva@rambler.ru

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 4, 2015

Study Start

April 1, 2015

Primary Completion

June 15, 2018

Study Completion

July 10, 2018

Last Updated

September 1, 2021

Results First Posted

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)