NCT02734719

Brief Summary

Bonestim system for osteoporosis treatment uses surface electrical stimulation of neuromuscular and skeletal tissue by multipad stimulation electrodes for inducing contractions of the spinal column muscles. The primary aim of this clinical study is to determine if the Bonestim therapy can improve bone density. A secondary aim is to determine whether the applied treatment increases postural stability and facilitation of daily life activities. Inducing of contractions of the spinal column muscles in this manner could be new treatment options for the patients with reduced mobility and the patients with serious contraindications for drugs.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
5.5 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

March 29, 2016

Last Update Submit

November 27, 2023

Conditions

OsteoporosisElectrical StimulationPosture

Outcome Measures

Primary Outcomes (1)

  • density of bone measured by central Dxa measurement

    6 months

Secondary Outcomes (2)

  • sagittal flexibility measured by Schober measurement

    6 months

  • daily activities measured by Oswestry disability index

    6 months

Study Arms (1)

Group treated with Bonestim

EXPERIMENTAL

The experimental group will be treated with the electrical stimulation device Bonestim.

Device: Bonestim

Interventions

BonestimDEVICE

Bonestim is the multipad electrical stimulation device.

Also known as: multipad electrical stimulation of trunk muscles
Group treated with Bonestim

Eligibility Criteria

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

You may qualify if:

  • T score at least 1,5 (ideal 2,-2,5)
  • Stable bone turn over (lab.analyses.)

You may not qualify if:

  • fracture,pace maker, malignancy and gastrointestinal problems
  • chronic corticosteroid therapy
  • spinal surgery in previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 12, 2016

Study Start

October 1, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

SE(1)