NCT03688282 is a NA clinical trial of Wearable vibration belt in Osteopenia, sponsored by Theranova, L.L.C..

Who is sponsoring NCT03688282?

NCT03688282 is sponsored by Theranova, L.L.C..

What drugs are being tested in NCT03688282?

Interventions in NCT03688282: Wearable vibration belt, Sham, wearing belt.

What condition does NCT03688282 study?

NCT03688282 studies Osteopenia.

Is NCT03688282 still recruiting?

NCT03688282 is currently completed. Last updated 27 April 2021.

Are results published for NCT03688282?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-04-27 · How we verify

NCT03688282

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2

Completed NA Results posted Last updated 27 April 2021

What this trial tests

NA trial testing Wearable vibration belt in Osteopenia in 18 participants. Completed in 17 April 2019.

Timeline

11 July 2018

Primary endpoint
29 November 2018

17 April 2019

Quick facts

Lead sponsor	Theranova, L.L.C.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	18
Start date	11 July 2018
Primary completion	29 November 2018
Estimated completion	17 April 2019
Sites	1 location across United States

Drugs / interventions tested

Wearable vibration belt
Sham, wearing belt

Conditions studied

Osteopenia — all drugs for Osteopenia →

Sponsor

Theranova, L.L.C.

Who can join

Eligibility, female only, with Osteopenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Blood-based Biomarker of Bone Loss Primary · Baseline and 30 minutes after completing the 30-minute treatment session

Percent change in NTX, a biomarker of bone loss activity measured in the blood. Percent change in NTX was determined from Baseline (pre-treatment) to 30-minutes post-treatment for the sham treatment and the active treatments. The difference in percent change was then compared between active and sham treatments.

Group	Value	95% CI
Sham Treatment Session	8.8	± 7.6
Active Treatment Session	-5.4	± 8.8

Sponsor's own description

The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. We propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to whole body vibration and is plausibly more effective at preventing bone loss in postmenopausal women than vibration platforms in the home setting.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Osteopenia

Currently open trials in the same condition.

NCT07473713 — Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia · Phase 1 · recruiting
NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
NCT07412782 — REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD) · NA · recruiting
NCT07187518 — Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device · NA · recruiting
NCT07191353 — Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women · Phase 2 · recruiting

Other Theranova, L.L.C. trials

Trials by the same sponsor.

NCT06760572 — Airway Data Collection With the Entarik Feeding Tube System · NA · recruiting
NCT05948605 — EMPOWER AUD Pivotal Trial · NA · completed
NCT05162833 — Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder Symptoms · NA · completed
NCT04758247 — Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms · NA · completed
NCT04901481 — Empower Neuromodulation System - Pilot Study for Anxiety Treatment · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03688282 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Theranova, L.L.C.
Last refreshed: 27 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03688282.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing