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

NCT06608862 | Recruiting DMC

• 1 other identifier: Female Health
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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; Muscle Strength; Bone Density; Contraception Behavior; Physical Activity; Menstrual Irregularities

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

Outcome Measures

Primary Outcomes (1)

• T-Score

  Changes in bone density T-Scores measured via ultra-sonic

  Measured at baseline and at 12 months after enrollment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: The study focuses on female soldiers, which are underrepresented in research.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female soldiers between 18-35 years.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bundeswehr University Munich: lead

Study Sites (1)

University of the Bundeswehr Munich

Munich, Bavaria, 85577, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A drop of capillary blood from the fingertip is collected for hemoglobin analysis

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Contraception Behavior; Motor Activity; Menstruation Disturbances

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Reproductive Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jennifer Schlie, M.Sc. Biomedical Science

CONTACT

0049 89 6004 4774; jennifer.schlie@unibw.de

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Annette Schmidt

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: October 1, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

DE (1)