Status:
COMPLETED
A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
Lead Sponsor:
Worcester Polytechnic Institute
Collaborating Sponsors:
Northwestern University
Conditions:
Bone Loss
Eligibility:
FEMALE
21-40 years
Phase:
NA
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...
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 pe...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04135196
Start Date
January 14 2014
End Date
July 19 2019
Last Update
October 18 2023
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