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

Description

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 researcher determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

Conditions

Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

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Study Overview

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Study Details

Study overview

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 researcher determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

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

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

Condition
Stage I Prostate Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

New Orleans

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States, 70121

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 60 years or older
  • * Be starting ADT or have received their first ADT treatment in the past 3 months, with at least 6 planned months of treatment remaining (both luteinizing hormone-releasing hormone (LHRH) antagonists and LHRH agonists are permitted)
  • * Have a total serum vitamin D between 10 and 27 ng/ml
  • * Have an total serum calcium of less than or equal to 10.5 mg/dl
  • * Have a normal GFR (glomerular filtration rate)
  • * 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
  • * Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or 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 10.5 mg/dl)
  • * Have a history of hypercalcemia or vitamin D toxicity/sensitivity

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester NCORP Research Base,

Luke J Peppone, PRINCIPAL_INVESTIGATOR, University of Rochester NCORP Research Base

Study Record Dates

2027-05-31