ContraceptionBeWOMENNCT06961773
Bone Metabolism in Premenopausal Exercising Women
A study testing Low energy availability and High energy availability in people with Contraception and Bone Metabolism, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Bone Metabolism, Low Energy Availability
- What is being tested?
- Low energy availability and High energy availability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2024to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Faculty of physical activity and sport sciences
Madrid, Comunity of Madrid, 28040
About this study
Official title: Bone Metabolism in Exercising WOMEN: Influence of Low Energy Availability and Sex Hormone Fluctuations
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?
Read more
- 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?
Read the detailed description
To achieve the aim of the study, there will be two experimental groups - e.g. eumenorrhoeic females and oral contraceptive users - who, after screening, will be randomly assigned to a low- or high-energy diet. After 6 days on this diet, the participant will undergo an intervallic running protocol and blood samples will be taken before and after the test. The following month the participant will do the other type of diet.
- Conditions
- Contraception, Bone Metabolism, Low Energy Availability, Eumenorrhea
- Being tested
- Low energy availability, High energy availability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy availabilityOther
Participants 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 availabilityOther
Participants follow 6 days of a high-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass.
| Study group | Role | What they receive |
|---|---|---|
| Eumhenorreic females | Experimental | Not described Receives: Other: Low energy availability; Other: High energy availability |
| Oral concetraceptive users | Experimental | Not described Receives: Other: Low energy availability; Other: High energy availability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: At the screening phase
Secondary outcomes (3)
Training status variables
Oxygen uptake at ventilatory threshold 1, ventilatory threshold 2, and maximal oxygen uptake (ml/kg/min) measured with a gas analyser.
Measured: At the screening phase
Body composition variables
Fat mass (kg), fat free mass (kg), fat mass percentage, fat-free mass percentage (FFM), total mass (kg) measured by dual x-ray absorptiometry
Measured: Immediately pre- and post-nutritional intervention (bioimpedance) and DXA at the screening
Body metrics
Height (cm)
Measured: Measured at the screening phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start5 Dec 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANA BELEN PEINADO LOZANO, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961773
- Sponsor's protocol ID
- 2023-091
- Acronym
- BeWOMEN
- Status last verified
- May 2025
- First submitted
- 6 Mar 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Metabolism in Exercising WOMEN: Influence of Low Energy Availability and Sex Hormone Fluctuations
- ClinicalTrials.gov ID
- NCT06961773
- Acronym / sponsor ID
- BeWOMEN / 2023-091
- Conditions
- Contraception, Bone Metabolism, Low Energy Availability, Eumenorrhea
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
- 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?
Detailed description
To achieve the aim of the study, there will be two experimental groups - e.g. eumenorrhoeic females and oral contraceptive users - who, after screening, will be randomly assigned to a low- or high-energy diet. After 6 days on this diet, the participant will undergo an intervallic running protocol and blood samples will be taken before and after the test. The following month the participant will do the other type of diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eumhenorreic females | Experimental | Other: Low energy availability, Other: High energy availability |
| Oral concetraceptive users | Experimental | Other: Low energy availability, Other: High energy availability |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low energy availabilityParticipants follow 6 days of a low-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass. | Other | Eumhenorreic females, Oral concetraceptive users |
| High energy availabilityParticipants follow 6 days of a high-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass. | Other | Eumhenorreic females, Oral concetraceptive users |
Primary outcome
Concentration of bone metabolism biomarkers
Time frame: immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise
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.
Concentrations of other biochemical biomarkers
Time frame: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise
Concentrations of Triiodothyronine (T3), Albumin, Sex Hormone Binding Globulin (SHBG), etc. measured in serum
Concentrations of sex hormones
Time frame: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise
Concentrations of 17β-Oestradiol and Progesterone measured in serum.
Bone mineral density
Time frame: At the screening phase
Total, lumbar spine and femoral neck bone mineral density (g/cm^2) measured by dual x-ray absorptiometry
3 secondary outcomes
Training status variables
Time frame: At the screening phase
Body composition variables
Time frame: Immediately pre- and post-nutritional intervention (bioimpedance) and DXA at the screening
Body metrics
Time frame: Measured at the screening phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low energy availability and High energy availability in people with Contraception and Bone Metabolism, run by Universidad Politecnica de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of bone metabolism biomarkers (time frame: immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.