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Vitamin d may shield bones from hormone therapy side effects

NCT ID NCT05838716

Disease control Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase III trial tests whether high-dose vitamin D can prevent bone loss in older men with prostate cancer who are receiving hormone therapy (ADT). The study will enroll 240 men aged 50 and older, giving them either high-dose vitamin D or a placebo for one year. Researchers will measure bone density, falls, and fatigue to see if the supplement helps keep bones strong.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vitamin D
What this could lead to
If it works, this could offer a simple, low-cost way to protect bone health in men undergoing hormone therapy for prostate cancer.
What could go wrong
This is a phase III trial, but vitamin D is already widely available, so the benefit may be modest. The study focuses on bone density, not cancer outcomes, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed) * Be age 50 years or older * Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \[LHRH\] antagonists and LHRH agonists are permitted) * Have a total serum vitamin D between 10 and 32 ng/ml * Have a total serum calcium of less than or equal to 10.5 mg/dl * Have a normal GFR (glomerular filtration rate \> 30ml) * Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study * Be able to provide written informed consent * Be able to swallow pills and capsules * Be able to speak and read English Exclusion Criteria: * Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment * Have a diagnosis of stage IV chronic kidney disease * Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl) * Have a history of hypercalcemia or vitamin D toxicity/sensitivity

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage I prostate cancer ajcc V8 Stage II prostate cancer ajcc V8 Stage III prostate cancer ajcc V8 Stage IVA prostate cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    51 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adena Regional Medical Center

    RECRUITING

    Chillicothe, Ohio, 45601, United States

  • Ballad Health Cancer Care - Bristol

    RECRUITING

    Bristol, Virginia, 24201, United States

  • Ballad Health Cancer Care - Kingsport

    RECRUITING

    Kingsport, Tennessee, 37660, United States

  • Bon Secours Cancer Institute at Reynolds Crossing

    RECRUITING

    Richmond, Virginia, 23230, United States

  • Bon Secours Memorial Regional Medical Center

    RECRUITING

    Mechanicsville, Virginia, 23116, United States

  • Bon Secours Saint Francis Medical Center

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • Bon Secours Saint Mary's Hospital

    RECRUITING

    Richmond, Virginia, 23226, United States

  • Cancer Care Center of O'Fallon

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Cancer Care Specialists of Illinois - Decatur

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Carilion Roanoke Memorial Hospital

    RECRUITING

    Roanoke, Virginia, 24033, United States

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • CarolinaEast Medical Center

    RECRUITING

    New Bern, North Carolina, 28561, United States

  • Community Medical Center

    RECRUITING

    Scranton, Pennsylvania, 18510, United States

    Contact Email: •••••@•••••

  • Geisinger Cancer Center Dickson City

    RECRUITING

    Dickson City, Pennsylvania, 18519, United States

    Contact Email: •••••@•••••

  • Geisinger Wyoming Valley/Henry Cancer Center

    RECRUITING

    Wilkes-Barre, Pennsylvania, 18711, United States

    Contact Email: •••••@•••••

  • Gibbs Cancer Center-Gaffney

    RECRUITING

    Gaffney, South Carolina, 29341, United States

  • Gibbs Cancer Center-Pelham

    RECRUITING

    Greer, South Carolina, 29651, United States

  • Gundersen Lutheran Medical Center

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

    Contact Email: •••••@•••••

  • Helen F Graham Cancer Center

    RECRUITING

    Newark, Delaware, 19713, United States

  • Louisiana State University Health Science Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Medical Oncology Hematology Consultants PA

    RECRUITING

    Newark, Delaware, 19713, United States

  • Mercy Hospital

    RECRUITING

    Coon Rapids, Minnesota, 55433, United States

  • Mercy Hospital Saint Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Minnesota Oncology Hematology PA-Maplewood

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • Nash UNC HealthCare

    RECRUITING

    Rocky Mount, North Carolina, 27804, United States

  • Ochsner Medical Center Jefferson

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • OptumCare Cancer Care at Charleston

    RECRUITING

    Las Vegas, Nevada, 89102, United States

    Contact Email: •••••@•••••

  • Park Nicollet Clinic - Saint Louis Park

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Regional Cancer Center at Johnson City Medical Center

    RECRUITING

    Johnson City, Tennessee, 37604, United States

  • Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • Ridgeview Medical Center

    RECRUITING

    Waconia, Minnesota, 55387, United States

  • SMC Center for Hematology Oncology Union

    RECRUITING

    Union, South Carolina, 29379, United States

  • Saint Francis Cancer Center

    RECRUITING

    Greenville, South Carolina, 29607, United States

  • Saint Francis Hospital

    RECRUITING

    Greenville, South Carolina, 29601, United States

  • Saint John's Hospital - Healtheast

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • Saint Vincent Hospital Cancer Center Green Bay

    RECRUITING

    Green Bay, Wisconsin, 54301, United States

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    RECRUITING

    Green Bay, Wisconsin, 54303, United States

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    RECRUITING

    Sturgeon Bay, Wisconsin, 54235-1495, United States

  • Spartanburg Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • University Medical Center New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Cancer Center - Lee's Summit

    RECRUITING

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    RECRUITING

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center-Overland Park

    RECRUITING

    Overland Park, Kansas, 66210, United States

  • University of Kansas Health System Saint Francis Campus

    RECRUITING

    Topeka, Kansas, 66606, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • VCU Massey Cancer Center at Stony Point

    RECRUITING

    Richmond, Virginia, 23235, United States

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

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Other studies related to the condition(s) this trial covers.