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Trial record 1 of 1 for:    05838716
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High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT05838716
Recruitment Status : Recruiting
First Posted : May 1, 2023
Last Update Posted : January 18, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Luke Peppone, University of Rochester NCORP Research Base

Study Description
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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
Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 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:

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 OBJECTIVES:

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

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

III. 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : December 14, 2023
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : May 31, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arms and Interventions
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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 Name: 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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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 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 [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05838716


Contacts
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Contact: Olivia Tauriello 585-275-8507 Olivia_Tauriello@URMC.Rochester.edu

Locations
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United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Eileen Mederos    504-842-3000    emede1@lsuhsc.edu   
Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Luke J Peppone University of Rochester NCORP Research Base
More Information
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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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC-22053 ( Other Identifier: University of Rochester NCORP Research Base )
URCC-22053 ( Other Identifier: DCP )
URCC-22053 ( Other Identifier: CTEP )
R01CA258349 ( U.S. NIH Grant/Contract )
UG1CA189961 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2023    Key Record Dates
Last Update Posted: January 18, 2024
Last Verified: January 2024

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
 Male Urogenital Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents