CompletedNot Applicable

Enhancing Skeletal Adaptations to PTH and Exercise

United States18 participantsStarted 2023-01-01

Plain-language summary

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.

Who can participate

Age range

25 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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. Exclusion Criteria: * 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 G…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in C-terminal Peptide of Type 1 Collagen (CTX)

Timeframe: The primary outcome for Aim 1 is the change in CTX from immediately before exercise to 60 minutes after exercise during the 1st, 8th, and 16th exercise bout. Results are for each exercise bout and for the average of all the bouts combined.

Change in Procollagen 1 Intact N-terminal Propeptide (P1NP)

Timeframe: The primary outcome for Aim 2 is the change in the pre-exercise P1NP (15 minutes before exercise) between the 1st and the 16th exercise bout (comparison of 2 time points).

Trial details

NCT IDNCT05029128

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-04-01

Results submitted2026-02-19

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