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High-Dose Vitamin D for Bone Loss in Prostate Cancer

Phase 3
Recruiting
Led By Luke J Peppone
Research Sponsored by University of Rochester NCORP Research Base
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 60 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 52 weeks
Awards & highlights

Summary

This trial is testing whether high-dose vitamin D can help treat bone loss in prostate cancer patients who are undergoing androgen-deprivation therapy. Vitamin D is important for the body to absorb calcium, which

Who is the study for?
This trial is for men aged 60 or older with Stage I-IV prostate cancer, starting androgen-deprivation therapy (ADT) without bone metastases. Participants must have started ADT within the last 3 months, plan to continue it for at least another 6 months, have specific levels of vitamin D and calcium in their blood, normal kidney function, and not take other calcium/vitamin D supplements.
What is being tested?
The study tests if high-dose vitamin D can prevent bone loss caused by ADT in older prostate cancer patients. It involves taking either high-dose vitamin D or a placebo while undergoing regular assessments like bone scans and quality-of-life surveys to see if there's an improvement in bone health, reduction in falls, or less fatigue.
What are the potential side effects?
Potential side effects from high doses of vitamin D may include elevated blood calcium levels which could cause confusion, digestive issues like nausea or vomiting; increased urination; weakness; and potential heart rhythm problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have prostate cancer stages I-IV without bone spread, but lymph nodes may be involved.
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I am 60 years old or older.
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I agree to only take calcium and vitamin D supplements given by the study.
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My kidney function is normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction of BMD loss as measured at the lumbar spine
Reduction of bone mineral density (BMD) loss as measured at the total hip

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (HDVD)Experimental Treatment5 Interventions
Patients receive HDVD PO throughout the study. Patients also undergo collection of blood and DXA scan on study.
Group II: Arm II (placebo, DXA scan, blood collection, questionnaire)Placebo Group5 Interventions
Patients receive placebo PO throughout the study. Patients also undergo collection of blood and DXA scan on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Dual X-ray Absorptiometry
2015
N/A
~50

Find a Location

Who is running the clinical trial?

University of Rochester NCORP Research BaseLead Sponsor
13 Previous Clinical Trials
8,777 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,634 Total Patients Enrolled
567 Trials studying Prostate Cancer
529,809 Patients Enrolled for Prostate Cancer
Luke J PepponePrincipal InvestigatorUniversity of Rochester NCORP Research Base
~244 spots leftby May 2026
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