Clinical trial NCT04135196: A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
Official title: A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Keywords: bone
adaptation
mechanical stimuli
women
peak bone mass
Lead sponsor: Worcester Polytechnic Institute
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2019-10-22
Enrollment: 102
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.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).

Eligibility criteria: Inclusion Criteria:

* Female
* Age 21-40
* Body Mass Index \[18-29\]
* 9-14 menstrual cycles/year
* Dual energy X-ray Absorptiometry total radius bone mineral density (BMD) T-score \[-2.5-+1\]
* Free of endocrinopathies
* No known thyroid, vitamin D, or calcium abnormalities

Exclusion Criteria:

* Fracture to wrist \<5 years ago
* Wrist Arthritis
* Injury to the non-dominant elbow or shoulder \<5 years ago
* Diabetes
* Severe disabling conditions
* Cancer \<5 years ago
* Metabolic bone disease
* Androgen, estrogen, progesterone, calcitonin, Selective Estrogen Receptor Modulators, Parathyroid hormone, gonadotropin-releasing hormone or analogs used \<6 months ago
* Corticosteroids \<3 months ago
* Bisphosphonates or fluoride \<3 years ago
* Cardiovascular/pulmonary disease
* Uncontrolled hypertension
* Regular Tobacco use
* Marijuana use \>1 time/week
* Alcohol \>4 drinks/day
* Pregnancy or lactation \<2 years ago
* Plan to become pregnant or donate eggs within 1 year
* Depot medroxyprogesterone acetate contraceptive \<6 months ago
* Current participation in upper extremity loading sports (gymnastics, tennis, softball, hockey) \>2 times/month
* Low calcium intake (avoiding dairy products without taking calcium supplement)

Primary outcomes:
measure: Change in UD iBMC
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Change in UD cBMC
timeFrame: baseline and 12 months
measure: Change in UD ecBMC
timeFrame: baseline and 12 months
measure: Change in UD tBMC
timeFrame: baseline and 12 months
measure: Change in UD iBMD
timeFrame: baseline and 12 months
measure: Change in UD cBMD
timeFrame: baseline and 12 months
measure: Change in UD ecBMD
timeFrame: baseline and 12 months
measure: Change in UD tBMD
timeFrame: baseline and 12 months
measure: Change in UD iBV
timeFrame: baseline and 12 months
measure: Change in UD cBV
timeFrame: baseline and 12 months
measure: Change in UD ecBV
timeFrame: baseline and 12 months
measure: Change in UD tBV
timeFrame: baseline and 12 months
measure: Change in Cortical Thickness
timeFrame: measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment
measure: Change in Trabecular BV/TV
timeFrame: measurements repeated at 0, 3, 6, 9, and 12 months from enrollment
Other outcomes:
Locations:
Study officials:
References:
citation: Mancuso ME, Johnson JE, Ahmed SS, Butler TA, Troy KL. Distal radius microstructure and finite element bone strain are related to site-specific mechanical loading and areal bone mineral density in premenopausal women. Bone Rep. 2018 Apr 14;8:187-194. doi: 10.1016/j.bonr.2018.04.001. eCollection 2018 Jun.
citation: Troy KL, Mancuso ME, Johnson JE, Wu Z, Schnitzer TJ, Butler TA. Bone Adaptation in Adult Women Is Related to Loading Dose: A 12-Month Randomized Controlled Trial. J Bone Miner Res. 2020 Jul;35(7):1300-1312. doi: 10.1002/jbmr.3999. Epub 2020 Mar 30.