Increasing Bone Density by Application of Surface Electri... | NCT02734719

Studies
Increasing Bone Density by Application of Surface Electrical Stimulation

NCT02734719

Sponsor

University of Belgrade

Status

Terminated

Last Update Posted

Nov 29, 2023Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Osteoporosis
Electrical Stimulation
Posture

Interventions

Bonestim

Countries

Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Device is not available.

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

May 30, 2023Actual

Completion Date

May 30, 2023Actual

First Submitted Date

Mar 29, 2016

First Submission Date that Met QC Criteria

Apr 5, 2016

First Posted Date

Apr 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group treated with Bonestim	Experimental	The experimental group will be treated with the electrical stimulation device Bonestim.	Device: Bonestim

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bonestim	Device	Bonestim is the multipad electrical stimulation device.	Group treated with Bonestim

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
density of bone measured by central Dxa measurement		6 months

Secondary Outcomes

Measure	Description	Time Frame
sagittal flexibility measured by Schober measurement		6 months
daily activities measured by Oswestry disability index		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade		Belgrade		11000	Serbia

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided