Enhancing Skeletal Adaptations to PTH and Exercise

Completed · Not applicable

Conditions studied: Exercise, Bone Resorption, Bone Formation

In brief

Exercise is essential for building and maintaining bone mass and strength, but current exercise recommendations for how to achieve this lack detail on the optimal exercise prescription. Recent studies found that blood calcium level decreases during exercise, and that calcium is mobilized from bone to slow the decline. If this occurs repeatedly during exercise training, it could diminish the potential benefits of exercise to improve bone health. The proposed study will determine whether further research on pre-exercise supplemental calcium to minimize the decline in blood calcium level during exercise is warranted. This research is important for Veterans because they are at increased risk of hip fracture when compared with non-Veterans. Further, because osteoporosis in men is under-recognized and under-treated, providing male (and female) Veterans with more specific exercise and nutrition guidelines has the potential to enhance bone health, reduce fracture risk, and improve quality of life.

Key facts

Study ID

NCT05029128

Run by

VA Office of Research and Development

People needed

18

Starts

2023-01-01

Expected to finish

2025-12-01

Last updated by the study team

2026-04-06

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Female and male Veterans aged 25 to 45 y and 55 to 75 y will be enrolled. Eligible volunteers will be normally active (e.g., recreational cycling or walking) but will not participate in regular moderate-to-vigorous exercise. Women will be premenopausal with regular menstrual cycles or postmenopausal, defined as absence of menses for at least 12 mo or, in those who underwent a hysterectomy, a serum follicle stimulating hormone (FSH) >30 mIU/mL.

You may not qualify if…

• Initiation or change in dose in the past 6 months of medications that affect bone metabolism
• e.g., osteoporosis medications, thiazide/loop diuretics, systemic glucocorticoids
• BMD T-score <-2.5 at the total hip, femoral neck, or lumbar spine
• Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2
• Abnormal alkaline phosphatase
• Untreated thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) <0.5 or >5.0 mU/L
• Serum Ca <8.5 or >10.3 mg/dL
• Serum 25(OH)D <20 ng/mL
• Uncontrolled hypertension (resting systolic blood pressure (BP) >150 mmHg or diastolic BP >90 mmHg)
• Type 1 diabetes
• Type 2 diabetes if on insulin or sulfonylurea therapy
• hemoglobin A1c >7%
• Cardiovascular disease; defined as subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT)
• volunteers who have a positive GXT can be re-considered after follow-up evaluation by a cardiologist
• Anemia (hemoglobin <12.1 g/dL for women, <14.3 g/dL for men)
• Fracture in the past 6 months
• Body mass index >39 kg/m2
• In the event of abnormal eGFR, alkaline phosphatase, TSH, BP, 25(OH)D, or hemoglobin values, volunteers can be reassessed, including after appropriate follow-up evaluation and treatment by their health care provider

Where it is running

• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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