Bone Metabolism in Premenopausal Exercising Women
- Sponsor
- Universidad Politecnica de Madrid
- Study ID
- NCT06961773
- Status
- Enrolling By Invitation
Conditions
- Bone Metabolism
- Contraception
- Eumenorrhea
- Low Energy Availability
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 30 Years
- Healthy Volunteers
- Accepted
Interventions
- Low energy availability — OTHERParticipants follow 6 days of a low-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass.
- High energy availability — OTHERParticipants follow 6 days of a high-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass.
Study Details
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?
Key Dates
- First listed
- May 8, 2025
- Start date
- Dec 5, 2024
- Status verified
- May 2025
- Primary completion
- Dec 20, 2025
- Completion
- Jun 15, 2026
Study Design
- Enrollment
- 22 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Eumhenorreic females
- Experimental: Oral concetraceptive users
Primary Outcome Measure
Concentration of bone metabolism biomarkers [ Time Frame: immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise ]
Related Studies
- Evaluation of the Efficacy, Safety, and Tolerability of LevoCeptPHASE3 · Not Yet Recruiting · Sebela Women's Health Inc. · Berkeley, California
- Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum PeriodRecruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
- Etonogestrel Implant as Emergency ContraceptionPHASE4 · Recruiting · University of Colorado, Denver · Aurora, Colorado
- Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day StartPHASE4 · Recruiting · University of Utah · San Jose, California