Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838716
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-04-20
Brief Title:
High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Sponsor:
University of Rochester NCORP Research Base
Organization:
University of Rochester
Study Overview
Official Title:
High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Luminexenzyme-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
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 Luminexenzyme-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1CA189961 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA189961 |
| NCI-2022-07664 | REGISTRY | None | None |
| URCC-22053 | OTHER | None | None |
| URCC-22053 | OTHER | None | None |
| URCC-22053 | OTHER | None | None |
| R01CA258349 | NIH | None | None |