OsteoporosisFHNCT06608862
The Impact of Hormonal Contraceptive Use and Lifestyle Factors on Fracture Risk and Bone Quality in Young Female Adults
An observational study of Osteoporosis and Osteopenia, run by Bundeswehr University Munich at 1 site in Germany.
Trial summary
The study on hand is based on a cross-sectional design and aims to acquire 1) descriptive data on the physical state and health condition of female soldiers in the German armed forces. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia, Fracture Reduction
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2023to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female soldiers between 18-35 years.
Who may be able to join
- 18 - 35 years
- female
- willing to participate under a pseudonym
- occupational soldiers
- free from chronic or acute musculoskeletal injury
Who cannot join
- for the bioelectrical impedance: electronic implants like defibrillator, pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of the Bundeswehr Munich
Munich, Bavaria, 85577
Annette Prof. Dr. Schmidt, Prof. Dr., +49 89 6004 4181, annette.schmidt@unibw.de
Jennifer Schlie, M.Sc.
About this study
Official title: The Impact of Hormonal Contraceptive Use, Body Composition, Muscular Strength and Iron Status on Fracture Risk and Bone Quality in Adult Females from 18-35 Years
The study on hand is based on a cross-sectional design and aims to acquire 1) descriptive data on the physical state and health condition of female soldiers in the German armed forces. 2) a possible influence of different contraceptive methods as well as physical activity, body composition, strength, nutrition, and hemoglobin levels on bone health should be investigated.
- Conditions
- Osteoporosis, Osteopenia, Fracture Reduction, Body Composition, Nutrition, Hemoglobin
- Keywords
- impact of lifestyle factors on bone quality, impact of hormonal contraceptive use on bone quality, impact of body composition on bone quality, impact of nutrition and energy balance on bone quality, impact of amenorrhea on bone quality, impact of physical activity on bone quality, impact of the occupation soldier on bone quality, impact of muscle strength on bone quality
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Contraception Behavior, Motor Activity, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female soldiers | Female soldiers from the university of the Bundeswehr in Munich, which are all of German nationality and between 18 and 35 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-Score
Changes in bone density T-Scores measured via ultra-sonic
Measured: Measured at baseline and at 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Oct 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundeswehr University Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annette Schmidt, PhD, Bundeswehr University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608862
- Sponsor's protocol ID
- Female Health
- Acronym
- FH
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous data might be shared, however the German Bundeswehr owns the data by now and has to decide on any data issues.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hormonal Contraceptive Use, Body Composition, Muscular Strength and Iron Status on Fracture Risk and Bone Quality in Adult Females from 18-35 Years
- ClinicalTrials.gov ID
- NCT06608862
- Acronym / sponsor ID
- FH / Female Health
- Conditions
- Osteoporosis, Osteopenia, Fracture Reduction, Body Composition, Nutrition, Hemoglobin
- Keywords
- impact of lifestyle factors on bone quality, impact of hormonal contraceptive use on bone quality, impact of body composition on bone quality, impact of nutrition and energy balance on bone quality, impact of amenorrhea on bone quality, impact of physical activity on bone quality, impact of the occupation soldier on bone quality, impact of muscle strength on bone quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bundeswehr University MunichUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 23 Sep 2024 (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 study on hand is based on a cross-sectional design and aims to acquire 1) descriptive data on the physical state and health condition of female soldiers in the German armed forces. 2) a possible influence of different contraceptive methods as well as physical activity, body composition, strength, nutrition, and hemoglobin levels on bone health should be investigated.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female soldiers | – | –Female soldiers from the university of the Bundeswehr in Munich, which are all of German nationality and between 18 and 35 years of age. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female soldiers between 18-35 years.
Key inclusion criteria (5 listed)
- 18 - 35 years
- female
- willing to participate under a pseudonym
- occupational soldiers
- free from chronic or acute musculoskeletal injury
Key exclusion criteria (1 listed)
- for the bioelectrical impedance: electronic implants like defibrillator, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T-Score
Time frame: Measured at baseline and at 12 months after enrollment
Changes in bone density T-Scores measured via ultra-sonic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Undecided. Anonymous data might be shared, however the German Bundeswehr owns the data by now and has to decide on any data issues.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteopenia, run by Bundeswehr University Munich at 1 site in Germany.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Schlie, M.Sc. Biomedical Science (0049 89 6004 4774, jennifer.schlie@unibw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-Score (time frame: Measured at baseline and at 12 months after enrollment). 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 23 Sep 2024.