Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
URCC-22053
Description
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.
Trial arms
Trial start
2023-12-14
Estimated PCD
2026-05-31
Trial end
2027-05-31
Status
Recruiting
Phase
Early phase I
Treatment
Biospecimen Collection
Undergo collection of blood
Arms:
Arm I (HDVD), Arm II (placebo, DXA scan, blood collection, questionnaire)
Other names:
Biological Sample Collection, Biospecimen Collected, Specimen Collection
D Vitamin
Given PO
Arms:
Arm I (HDVD)
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
Dual X-ray Absorptiometry
Undergo DXA scan
Arms:
Arm I (HDVD), Arm II (placebo, DXA scan, blood collection, questionnaire)
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
Placebo Administration
Given PO
Arms:
Arm II (placebo, DXA scan, blood collection, questionnaire)
Quality-of-Life Assessment
Ancillary studies
Arms:
Arm I (HDVD), Arm II (placebo, DXA scan, blood collection, questionnaire)
Other names:
Quality of Life Assessment
Questionnaire Administration
Ancillary studies
Arms:
Arm I (HDVD), Arm II (placebo, DXA scan, blood collection, questionnaire)
Size
366
Primary endpoint
Reduction of bone mineral density (BMD) loss as measured at the total hip
At 52 weeks
Reduction of BMD loss as measured at the lumbar spine
At 52 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 366, 'type': 'ESTIMATED'}}
Updated at
2024-01-18

1 organization

1 product

2 indications

Organization
University of Rochester NCORP Research Base
Product
Placebo
Indication
Prostate Cancer
Indication
Prostate Cancer, Stage III AJCC v8