Bone Metabolism in Premenopausal Exercising Women (NCT06961773) | Clinical Trial Compass
By InvitationNot Applicable
Bone Metabolism in Premenopausal Exercising Women
Spain22 participantsStarted 2024-12-05
Plain-language summary
The main goal of this study is to examine how sex hormones and low energy availability affect the concentrations of bone remodelling markers at rest and after a running protocol. The research questions to be addressed are:
1: Does the ovarian hormone profile influence serum bone marker concentrations in women exercising resting and in response to to exercise?
2\. Are there differences in response to low energy availability in bone marker concentrations between eumenorrhoeic female athletes and oral contraceptive users?
3: Is the response of bone markers affected by different exercise stimuli: endurance or aerobic endurance?
4: Do bone markers return to baseline levels after 24 hours of high energy availability diet after 6 days of low energy availability?
Who can participate
Age range
18 Years – 30 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be healthy and between 18 and 30 years old.
* Engage in endurance sports that involve running (such as athletics, running, triathlon, trail running, etc.) for 3 to 12 hours per week..
* Eumenorrheic females with regular menstruation at least 6 months prior to the study.
* Monophasic oral contraceptive users at least 6 months prior to the study.
Exclusion Criteria:
* Amenorrheic females.
* Pregnant females.
* Affected by any disorder related to the hypothalamo-pituitary-ovarian axis.
* Having suffered a bone fracture in the year before the study.
* Taking any medication or supplements that affect bone metabolism.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of bone metabolism biomarkers
Timeframe: immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise
2
Concentrations of other biochemical biomarkers
Timeframe: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise
3
Concentrations of sex hormones
Timeframe: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise