The Impact of Hormonal Contraceptive Use and Lifestyle Factors on Fracture Risk and Bone Quality in Young Female Adults (FH)

September 19, 2024 updated by: Annette Schmidt, PhD, Bundeswehr University Munich

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Bayern
      • Munich, Bayern, Germany, 85577
        • Recruiting
        • University of the Bundeswehr Munich
        • Contact:
        • Contact:
          • Jennifer Schlie, M.Sc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Female soldiers between 18-35 years.

Description

Inclusion Criteria:

  • 18 - 35 years
  • female
  • willing to participate under a pseudonym
  • occupational soldiers
  • free from chronic or acute musculoskeletal injury

Exclusion Criteria:

  • for the bioelectrical impedance: electronic implants like defibrillator, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T-Score
Time Frame: Measured at baseline and at 12 months after enrollment
Changes in bone density T-Scores measured via ultra-sonic
Measured at baseline and at 12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bundeswehr University Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Female Health

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymous data might be shared, however the German Bundeswehr owns the data by now and has to decide on any data issues.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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