Vitamin D for Prostate Endocrine Therapy (ViPER)

January 14, 2026 updated by: Luke Peppone, University of Rochester

High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researchers determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the effect of high-dose vitamin D (HDVD) supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the total hip over 52 weeks as measured by dual-energy x-ray absorptiometry (DXA).

II. To evaluate the effect of HDVD supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the femoral neck, distal radius, and lumbar spine (L1-L4) over 52 weeks as measured by DXA.

SECONDARY OBJECTIVES:

I. To evaluate the effect of HDVD supplementation on falls over 52 weeks as measured by the Falls History questionnaire.

II. To evaluate the effect of HDVD supplementation on fractures over 52 weeks as determined by the Clinical Record Information - Follow-up Form.

III. To evaluate the effect of HDVD supplementation on quality of life over 52 weeks as measured by the Functional Assessment of Cancer Therapy- Prostate (FACT-P).

EXPLORATORY OBJECTIVE:

I. To evaluate the effect of HDVD supplementation on pain, fatigue, sleep, and activities of daily living over 52 weeks as measured by patient-reported outcomes.

OUTLINE: After undergoing collection of blood and DXA scan, patients are randomized to 1 of 2 arms.

ARM I: Patients receive HDVD orally (PO) once a week (QW) for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

ARM II: Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Illinois
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Vamsi K. Vasireddy
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Vamsi K. Vasireddy
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Vamsi K. Vasireddy
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Vamsi K. Vasireddy
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • University of Kansas Health System Saint Francis Campus
        • Principal Investigator:
          • Elizabeth M. Wulff
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Brian T. Halbert
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Rajasree P. Chowdry
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University Health Science Center
        • Contact:
        • Principal Investigator:
          • Rajasree P. Chowdry
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center - Lee's Summit
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • Khawaja S. Jahangir
    • North Carolina
      • New Bern, North Carolina, United States, 28561
        • Recruiting
        • CarolinaEast Medical Center
        • Principal Investigator:
          • Seth M. Miller
        • Contact:
      • Rocky Mount, North Carolina, United States, 27804
        • Recruiting
        • Nash UNC HealthCare
        • Contact:
          • Site Public Contact
          • Phone Number: 252-952-8000
        • Principal Investigator:
          • Elie B. Choufani
    • Ohio
      • Chillicothe, Ohio, United States, 45601
        • Recruiting
        • Adena Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Aruna C. Gowda
    • Pennsylvania
      • Dickson City, Pennsylvania, United States, 18519
        • Recruiting
        • Geisinger Cancer Center Dickson City
        • Principal Investigator:
          • Heath B. Mackley
        • Contact:
      • Scranton, Pennsylvania, United States, 18510
        • Recruiting
        • Community Medical Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Recruiting
        • Gibbs Cancer Center-Gaffney
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Saint Francis Hospital
        • Principal Investigator:
          • Stephen H. Dyar
        • Contact:
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center
        • Principal Investigator:
          • Stephen H. Dyar
        • Contact:
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Union, South Carolina, United States, 29379
        • Recruiting
        • SMC Center for Hematology Oncology Union
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Recruiting
        • Regional Cancer Center at Johnson City Medical Center
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Ballad Health Cancer Care - Kingsport
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
    • Virginia
      • Bristol, Virginia, United States, 24201
        • Recruiting
        • Ballad Health Cancer Care - Bristol
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Mechanicsville, Virginia, United States, 23116
        • Recruiting
        • Bon Secours Memorial Regional Medical Center
        • Contact:
        • Principal Investigator:
          • William J. Irvin
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • William J. Irvin
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • Asit K. Paul
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • William J. Irvin
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Bon Secours Cancer Institute at Reynolds Crossing
        • Contact:
        • Principal Investigator:
          • William J. Irvin
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Asit K. Paul
        • Contact:
      • Roanoke, Virginia, United States, 24033
        • Recruiting
        • Carilion Roanoke Memorial Hospital
        • Principal Investigator:
          • Asit K. Paul
        • Contact:
          • Site Public Contact
          • Phone Number: 540-981-7377
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Brian L. Burnette
        • Contact:
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Brian L. Burnette
        • Contact:
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Kurt Oettel
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Principal Investigator:
          • Brian L. Burnette
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (HDVD)
Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Dual X-ray Absorptiometry
Undergo DXA scan
Other Names:
  • DEXA
  • DXA
  • BMD scan
  • bone mineral density scan
  • DEXA Scan
  • dual energy x-ray absorptiometric scan
  • Dual Energy X-ray Absorptiometry
  • Dual X-Ray Absorptometry
  • DXA SCAN
  • DEXA (Bone Density)
Dietary supplement: D Vitamin
Given PO
Other Names:
  • Vitamin D
  • 3-[2-[7a-methyl-1-(1,4,5-trimethylhex-2-enyl)-1,2,3,3a,5,6,7,7a-octahydroinden-4-ylidene]ethylidene]-4-methylidene-cyclohexan-1-ol
  • Vitamin D Compound
  • Vitamin-D
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Placebo Administration
Given PO
Procedure: Dual X-ray Absorptiometry
Undergo DXA scan
Other Names:
  • DEXA
  • DXA
  • BMD scan
  • bone mineral density scan
  • DEXA Scan
  • dual energy x-ray absorptiometric scan
  • Dual Energy X-ray Absorptiometry
  • Dual X-Ray Absorptometry
  • DXA SCAN
  • DEXA (Bone Density)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of bone mineral density (BMD) loss as measured at the total hip
Time Frame: At 52 weeks
Will determine the efficacy of high-dose vitamin D (HDVD) supplementation versus placebo in reducing BMD loss as measured at the total hip via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of covariance (ANCOVA) with group (vitamin D or placebo) as the main factor, baseline timepoint ([T]1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial linear mixed model (LMM) will be fit using Restricted Maximum Likelihood (REML) estimation. The significance of the variance due to study site will be tested using the Wald Test.
At 52 weeks
Reduction of BMD loss as measured at the femoral neck
Time Frame: At 52 weeks
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the femoral neck via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.
At 52 weeks
Reduction of BMD loss as measured at the distal radius
Time Frame: At 52 weeks
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the distal radius via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.
At 52 weeks
Reduction of BMD loss as measured at the lumbar spine
Time Frame: At 52 weeks
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the lumbar spine via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.
At 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in falls
Time Frame: Baseline up to 52 weeks
Will use generalized linear mixed models. Logistic regression models will be used to estimate the between group difference in (1) the proportion of participants who experience a fall/fracture (YES/NO) from T1 to T3. Will evaluate the distribution of total number of falls/fractures by Poisson models analysis to estimate the between group difference in (2) the total number of falls/fractures from T1 to T3. Both models (1, 2) will contain group as fixed effect and site as a random effect. Additional adjustment covariates will include falls in the previous 6 months, fractures in the previous 5 years, androgen-deprivation therapy (ADT) dose and duration, stage, radiation therapy, prior surgery, baseline vitamin D, age, body mass index (BMI), and race. Nonsignificant (P > 0.05) covariates will be removed from the model. Will report the estimates and associated 95% confidence intervals as (1) relative risk or (2) rate ratio.
Baseline up to 52 weeks
Change in fractures
Time Frame: Baseline up to 52 weeks
Will use generalized linear mixed models. Logistic regression models will be used to estimate the between group difference in (1) the proportion of participants who experience a fall/fracture (YES/NO) from T1 to T3. Will evaluate the distribution of total number of falls/fractures by Poisson models analysis to estimate the between group difference in (2) the total number of falls/fractures from T1 to T3. Both models (1, 2) will contain group as fixed effect and site as a random effect. Additional adjustment covariates will include falls in the previous 6 months, fractures in the previous 5 years, ADT dose and duration, stage, radiation therapy, prior surgery, baseline vitamin D, age, BMI, and race. Nonsignificant (P > 0.05) covariates will be removed from the model. Will report the estimates and associated 95% confidence intervals as (1) relative risk or (2) rate ratio.
Baseline up to 52 weeks
Change in quality of life
Time Frame: Baseline up to 52 weeks
Will be evaluated by Functional Assessment of Cancer Therapy-Prostate Trial Outcome Index score.
Baseline up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Luke J Peppone, University of Rochester NCORP Research Base

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Estimated)

April 29, 2029

Study Completion (Estimated)

April 29, 2029

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URCC-22053 (Other Identifier: CTEP)
  • UG1CA189961 (U.S. NIH Grant/Contract)
  • NCI-2022-07664 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA258349 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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