OsteoporosisNCT02734719
Increasing Bone Density by Application of Surface Electrical Stimulation
A study testing Bonestim in people with Osteoporosis and Electrical Stimulation, run by University of Belgrade at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis, Electrical Stimulation, Posture
- What is being tested?
- Bonestim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Oct 2021to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- T score at least 1,5 (ideal 2,-2,5)
- Stable bone turn over (lab.analyses.)
Who cannot join
- fracture,pace maker, malignancy and gastrointestinal problems
- chronic corticosteroid therapy
- spinal surgery in previous year
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, 11000
About this study
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.
- Conditions
- Osteoporosis, Electrical Stimulation, Posture
- Being tested
- Bonestim
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonestimDevice
Also called multipad electrical stimulation of trunk muscles
Bonestim is the multipad electrical stimulation device.
| Study group | Role | What they receive |
|---|---|---|
| Group treated with Bonestim | Experimental | The experimental group will be treated with the electrical stimulation device Bonestim. Receives: Device: Bonestim |
What is being measured
The primary outcome is the main question the study is designed to answer.
density of bone measured by central Dxa measurement
Measured: 6 months
Secondary outcomes (2)
sagittal flexibility measured by Schober measurement
Measured: 6 months
daily activities measured by Oswestry disability index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start1 Oct 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Why it stopped: Device is not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinovic Ljubica, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734719
- Sponsor's protocol ID
- LK-2
- Status last verified
- Nov 2023
- First submitted
- 29 Mar 2016
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Bone Density by Application of Surface Electrical Stimulation
- ClinicalTrials.gov ID
- NCT02734719
- Acronym / sponsor ID
- LK-2
- Conditions
- Osteoporosis, Electrical Stimulation, Posture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device is not available.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group treated with Bonestim | Experimental | Device: BonestimThe experimental group will be treated with the electrical stimulation device Bonestim. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- T score at least 1,5 (ideal 2,-2,5)
- Stable bone turn over (lab.analyses.)
Key exclusion criteria (3 listed)
- fracture,pace maker, malignancy and gastrointestinal problems
- chronic corticosteroid therapy
- spinal surgery in previous year
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 |
|---|---|---|
| BonestimAlso: multipad electrical stimulation of trunk musclesBonestim is the multipad electrical stimulation device. | Device | Group treated with Bonestim |
Primary outcome
density of bone measured by central Dxa measurement
Time frame: 6 months
2 secondary outcomes
sagittal flexibility measured by Schober measurement
Time frame: 6 months
daily activities measured by Oswestry disability index
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Device is not available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonestim in people with Osteoporosis and Electrical Stimulation, run by University of Belgrade at 1 site in Serbia.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Nov 2023. 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 Serbia. 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?
The study was stopped early (reason given: Device is not available.). Results are not available in the source record.
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?
density of bone measured by central Dxa measurement (time frame: 6 months). 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 29 Nov 2023.