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Assessing the Impact of Contraceptives on Bone Health Using 41Ca
Sponsor: Penn State University
Summary
This preclinical randomized crossover study will examine the effects of oral versus non-oral contraceptive therapy on bone turnover in young exercising women. In an effort to expose the route-dependent effects of oral versus non-oral contraceptive therapy on bone turnover, the investigators will examine 1) the effects of ethinyl estradiol on bone calcium balance using the 41Ca technology and 2) the underlying physiological mechanisms associated with the effects of oral versus non-oral contraceptive therapy on net bone calcium balance.
Official title: The Effect of Oral vs. Non-oral Contraceptive Therapy on Bone Turnover Using 41Ca Methodology
Key Details
Gender
FEMALE
Age Range
18 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2015-01
Completion Date
2026-12
Last Updated
2025-05-13
Healthy Volunteers
Yes
Interventions
Combined Oral Contraceptive (COC)
The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral vs. non-oral ethinyl estradiol on net bone calcium balance. A prospective crossover study with repeated measures and a simple random assignment will be used to test the effects of 49 days of COC use on bone metabolism using 41Ca to determine net bone calcium balance. Subjects will be randomized to receive COC during either the first or second intervention period.
Contraceptive Vaginal Ring (CVR)
The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral vs. non-oral ethinyl estradiol on net bone calcium balance. A prospective crossover study with repeated measures and a simple random assignment will be used to test the effects of 49 days of CVR use on bone metabolism using 41Ca to determine net bone calcium balance. Subjects will be randomized to receive CVR during either the first or second intervention period.
Locations (1)
Women's Health and Exercise Laboratories, The Pennsylvania State University
University Park, Pennsylvania, United States