N/A
N=14
Impact Loading Effect on Bone Biomarkers in Female Runners
Relative Energy Deficiency in Sport
Bottom Line
View on ClinicalTrials.gov: NCT05341700 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen — -3.1; 1.1 ng/mL — p=0.246
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Impact Load Exercises (Behavioral); No Impact Load Exercises (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Virginia Polytechnic Institute and State University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen |
-3.1; 1.1 | 0.246 |
| PRIMARY Change in Bone Remodeling Biomarker - C-terminal Telopeptide of Type 1 Collagen (CTX) |
0.04; 0.04 | 0.714 |
| PRIMARY Change in Blood Metabolic Marker - Parathyroid Hormone |
3.3; -1.0 | 0.309 |
| PRIMARY Change in Blood Metabolic Marker - Insulin-like Growth Factor-1 |
-11.4; -8.0 | 0.308 |
| SECONDARY Change in Ferritin |
4.1; 11.4 | 0.207 |
Summary
This study is a randomized, cross-over intervention study that will evaluate the effect of brief, high-impact loading exercises on biomarkers of bone metabolism in energy-restricted female runners. Volunteers will complete two 5-day experimental conditions in a randomized order separated by one menstrual cycle (approximately 3 weeks). Experimental conditions will include a dietary intervention of energy intake equal to 30 kcal/kg of fat-free mass/d using controlled diets and an exercise intervention of daily treadmill running with or without an additional 50 impact loading exercises.
Eligibility Criteria
Inclusion Criteria
- Females runners with regular menstrual cycles, not using contraceptives
- Body Mass Index between 18.5-30.0 kg/m2
- Weight stable (+/- 2 kg) for 6 months
- VO2max of ≥35 ml/kg/min
- Willing to consume provided meals and snacks
Exclusion Criteria
- Low Energy Availability in Females Questionnaire (LEAF-Q) score ≥8
- Menstrual disturbances measured by progesterone and self-report
- Using contraceptives (oral contraceptives, injections, intrauterine device, etc.)
- Low Bone Mineral Density (z-score < -1)
- Routine engagement in mechanical loading exercises
- History of fracture in the previous 6 months
- Recent recovery (within the last 12 months) or still in recovery after eating disorder diagnosis
- Medication use that could affect bone metabolism (e.g., corticosteroids, anticonvulsants, heparin, gonadotropin-releasing hormone agonists)
- Pregnancy or lactation
- Abnormal thyroid-stimulating hormone levels
Data sourced from ClinicalTrials.gov (NCT05341700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.