Trial Title:
High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
NCT ID:
NCT05838716
Condition:
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood
Arm group label:
Arm I (HDVD)
Arm group label:
Arm II (placebo, DXA scan, blood collection, questionnaire)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Dietary Supplement
Intervention name:
D Vitamin
Description:
Given PO
Arm group label:
Arm I (HDVD)
Other name:
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
Other name:
Vitamin D
Other name:
Vitamin D Compound
Other name:
Vitamin-D
Intervention type:
Procedure
Intervention name:
Dual X-ray Absorptiometry
Description:
Undergo DXA scan
Arm group label:
Arm I (HDVD)
Arm group label:
Arm II (placebo, DXA scan, blood collection, questionnaire)
Other name:
BMD scan
Other name:
bone mineral density scan
Other name:
DEXA
Other name:
DEXA (Bone Density)
Other name:
DEXA Scan
Other name:
dual energy x-ray absorptiometric scan
Other name:
Dual Energy X-ray Absorptiometry
Other name:
Dual X-Ray Absorptometry
Other name:
DXA
Other name:
DXA SCAN
Intervention type:
Drug
Intervention name:
Placebo Administration
Description:
Given PO
Arm group label:
Arm II (placebo, DXA scan, blood collection, questionnaire)
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm I (HDVD)
Arm group label:
Arm II (placebo, DXA scan, blood collection, questionnaire)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (HDVD)
Arm group label:
Arm II (placebo, DXA scan, blood collection, questionnaire)
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.
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.
Criteria for eligibility:
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
Gender:
Male
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ochsner Medical Center Jefferson
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eileen Mederos
Phone:
504-842-3000
Email:
emede1@lsuhsc.edu
Start date:
December 14, 2023
Completion date:
May 31, 2027
Lead sponsor:
Agency:
University of Rochester NCORP Research Base
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05838716
