The Impact of Hormonal Contraceptive Use and Lifestyle Fa... | NCT06608862

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

NCT06608862

Sponsor

Bundeswehr University Munich

Status

Recruiting

Last Update Posted

Sep 23, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Osteoporosis
Osteopenia
Fracture Reduction
Body Composition
Nutrition
Hemoglobin
Muscle Strength
Bone Density
Contraception Behavior
Physical Activity
Menstrual Irregularities

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Jan 31, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Sep 17, 2024

First Submission Date that Met QC Criteria

Sep 19, 2024

First Posted Date

Sep 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2024

Last Update Posted Date

Sep 23, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annette Schmidt, PhD, Prof. Dr. Annette Schmidt, Bundeswehr University MunichPrincipal Investigator

Lead Sponsor

Bundeswehr University MunichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

The study focuses on female soldiers, which are underrepresented in research.

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Female soldiers between 18-35 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jennifer Schlie, M.Sc. Biomedical Science	Contact	0049 89 6004 4774		jennifer.schlie@unibw.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of the Bundeswehr Munich	Recruiting	Munich	Bavaria	85577	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
D003268	Contraception Behavior
D009043	Motor Activity
D008599	Menstruation Disturbances

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D043762	Reproductive Behavior
D001519	Behavior
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms