NCT04135196

A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Worcester Polytechnic Institute · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to understand how different types of mechanical forces can influence bone adaptation (and make bones stronger, potentially). Forces acting on bones cause mechanical strain. In small animals, strain magnitude and rate have been shown to stimulate bone adaptation. This study is designed to test the degree to which strain magnitude and rate govern bone adaptation in healthy adult women.

Detailed description

The study consists of three Aims: Aim 1: compare the effect on bone structure of mechanical signals with low strain magnitude, high strain magnitude, and control groups over a 12-month prospective period. Aim 2. Compare the effect on bone structure of mechanical signals with low strain rate, high strain rate, and control groups over a 12-month prospective period. Aim 3: Examine the effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn. The intervention is a voluntary forearm compression task, consisting of leaning onto the palm of the hand to produce a target force. The primary outcome measure is change in distal radius bone mineral content (BMC).

Conditions

• Bone Loss

Interventions

Type	Name	Description
OTHER	voluntary forearm loading task	voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.

Timeline

• Start date: 2014-01-14
• Primary completion: 2018-06-29
• Completion: 2019-07-19
• First posted: 2019-10-22
• Last updated: 2023-10-18
• Results posted: 2023-10-18