Clincosm LogoSign in Get a demo

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

Sponsor
University of Rochester NCORP Research Base (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05838716
Collaborator
National Cancer Institute (NCI) (NIH)
366
Enrollment
2
Arms
45.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Dietary Supplement: D Vitamin
  • Procedure: Dual X-ray Absorptiometry
  • Drug: Placebo Administration
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 Phase 3

Detailed Description

PRIMARY OBJECTIVES:

  1. 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).

  2. 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:

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

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

  3. 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 OBJECTIVES:

  1. To explore the effect of HDVD supplementation on skeletal muscle mass as measured by DXA.

  2. To explore the effect of HDVD supplementation on bone biomarkers measured by Millipore Luminex/enzyme-linked immunosorbent assay (ELISA) assays from serum.

  3. 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, patents are randomized to 1 of 2 arms.

ARM I: Patients receive HDVD orally (PO) throughout the study. Patients also undergo collection of blood and DXA scan on study.

ARM II: Patients receive placebo PO throughout the study. Patients also undergo collection of blood and DXA scan on study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
366 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Anticipated Study Start Date :
Aug 5, 2023
Anticipated Primary Completion Date :
May 31, 2026
Anticipated Study Completion Date :
May 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (HDVD)

Patients receive HDVD PO throughout the study. Patients also undergo collection of blood and DXA scan on study.

Procedure: Biospecimen Collection
Undergo collection of blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

    • Dietary Supplement: D Vitamin
    Given PO
    Other Names:
  • 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
  • Vitamin D Compound
  • Vitamin-D

    • Procedure: Dual X-ray Absorptiometry
    Undergo DXA scan
    Other Names:
  • BMD scan
  • bone mineral density scan
  • DEXA
  • DEXA (Bone Density)
  • DEXA Scan
  • dual energy x-ray absorptiometric scan
  • Dual Energy X-ray Absorptiometry
  • Dual X-Ray Absorptometry
  • DXA
  • DXA SCAN

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies
    Placebo Comparator: Arm II (placebo, DXA scan, blood collection, questionnaire)

    Patients receive placebo PO throughout the study. Patients also undergo collection of blood and DXA scan on study.

    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:
  • BMD scan
  • bone mineral density scan
  • DEXA
  • DEXA (Bone Density)
  • DEXA Scan
  • dual energy x-ray absorptiometric scan
  • Dual Energy X-ray Absorptiometry
  • Dual X-Ray Absorptometry
  • DXA
  • DXA SCAN

    • Drug: Placebo Administration
    Given PO

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Reduction of bone mineral density (BMD) loss as measured at the total hip [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 via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of variance (ANCOVA) with Group (vitamin D or placebo) as the main factor, baseline BMD as covariate, and T3 (week 52) 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.

    2. Reduction of BMD loss as measured at the lumbar spine [At 52 weeks]

      Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the lumbar spine total via DXA at 52 weeks. Will use ANCOVA with Group (vitamin D or placebo) as the main factor, baseline BMD as covariate, and T3 (week 52) 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Rochester NCORP Research Base
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luke Peppone, Principal Investigator, University of Rochester NCORP Research Base
    ClinicalTrials.gov Identifier:
    NCT05838716
    Other Study ID Numbers:
    • URCC-22053
    • NCI-2022-07664
    • URCC-22053
    • URCC-22053
    • URCC-22053
    • R01CA258349
    • UG1CA189961
    First Posted:
    May 1, 2023
    Last Update Posted:
    May 1, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of May 1, 2023