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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 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 |
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.
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Procedure: Biospecimen Collection
Undergo collection of blood
Other Names:
Dietary Supplement: D Vitamin Given PO
Other Names:
Procedure: Dual X-ray Absorptiometry Undergo DXA scan
Other Names:
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:
Procedure: Dual X-ray Absorptiometry Undergo DXA scan
Other Names:
Drug: Placebo Administration Given PO Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- 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.
- 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.
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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
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
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
Contact: Olivia Tauriello | 585-275-8507 | Olivia_Tauriello@URMC.Rochester.edu |
United States, Louisiana | |
Ochsner Medical Center Jefferson | Recruiting |
New Orleans, Louisiana, United States, 70121 | |
Contact: Eileen Mederos 504-842-3000 emede1@lsuhsc.edu |
Principal Investigator: | Luke J Peppone | University of Rochester NCORP Research Base |
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 |
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 |
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 |