Bone Metabolism in Premenopausal Exercising Women

NCT06961773 | Enrolling By Invitation

• 1 other identifier: 2023-091
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Contraception; Bone Metabolism; Low Energy Availability; Eumenorrhea

Outcome Measures

Primary Outcomes (4)

• Concentration of bone metabolism biomarkers

  Concentration of procollagen type I N-propeptide (P1NP), cross-linking telopeptide of type I collagen (βCTX-1), paratyroid hormone, calcium, sclerostin, osteoprotegin, osteocalcin, bone alkaline phospatase, Receptor Activator for Nuclear Factor κ B Ligand (RANKL) measured in serum samples.

  immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise

• Concentrations of other biochemical biomarkers

  Concentrations of Triiodothyronine (T3), Albumin, Sex Hormone Binding Globulin (SHBG), etc. measured in serum

  Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise

• Concentrations of sex hormones

  Concentrations of 17β-Oestradiol and Progesterone measured in serum.

  Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise

• Bone mineral density

  Total, lumbar spine and femoral neck bone mineral density (g/cm\^2) measured by dual x-ray absorptiometry

  At the screening phase

Secondary Outcomes (3)

• Training status variables

  At the screening phase

• Body composition variables

  Immediately pre- and post-nutritional intervention (bioimpedance) and DXA at the screening

• Body metrics

  Measured at the screening phase

Study Arms (2)

Eumhenorreic females

EXPERIMENTAL

Other: Low energy availability; Other: High energy availability

Oral concetraceptive users

EXPERIMENTAL

Other: Low energy availability; Other: High energy availability

Interventions

Low energy availability OTHER

Participants follow 6 days of a low-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass.

Eumhenorreic females; Oral concetraceptive users

High energy availability OTHER

Participants follow 6 days of a high-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass.

Eumhenorreic females; Oral concetraceptive users

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Politecnica de Madrid: lead

Study Sites (1)

Faculty of physical activity and sport sciences

Madrid, Comunity of Madrid, 28040, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: May 8, 2025
• Study Start: December 5, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)