Bone Mineral Density Quantitative Trait Locus 3, Prostatic Neoplasms
Conditions
Keywords
prostate cancer, bone density, vitamin D, micronutrients, pharmacologic actions
Brief summary
The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60 and older, beginning ADT, and scheduled to receive at least 6 months more of ADT. Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin and calcium supplement.
Detailed description
The investigators hypothesize high-dose vitamin D supplementation will reduce androgen deprivation therapy (ADT)-related side effects including ADT-induced bone loss, decreased muscle mass, falls, reduced muscle strength, and diminished physical performance in older prostate cancer patients. The vitamin D supplementation is aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both vitamin D and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on prostate cancer patients and survivors. Vitamin D could reduce fracture risk among prostate cancer survivors.
Interventions
DIETARY_SUPPLEMENTvitamin D
50,000IU/week of vitamin D3
DIETARY_SUPPLEMENTPlacebo
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
60 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Have a confirmed diagnosis of stage I-IIIA prostate cancer * Within 6 months of starting ADT with an additional 6 more months planned. * Participants must have sub-optimal vitamin D levels of \<32 ng/ml. * Participants must agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided. * Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of ≤10.5 mg/dl. * No contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician. * Able to read English (since the assessment materials are in printed format). * Able to swallow medication and provide written informed consent. * 60 years of age or older.
Exclusion criteria
* Previously verified diagnosis of osteoporosis (any t-score ≤ -2.5). * Patients on antiresorptive drugs (i.e. bisphosphonates) within the past year. * Patients with hypercalcemia (corrected serum Ca \> 10.5 mg/dl) or a history of hypercalcemia or vitamin D toxicity/sensitivity. * Patients with impaired renal function (CrCl \< 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years. * Myocardial infarction within the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density | after 24 weeks | mean difference in bone mineral density between treatment group and control group |
| bone biomarkers | after 24 weeks | amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| muscle mass | after 24 weeks | muscle mass as assessed by dual energy x-ray absorptiometry |
| muscular strength | after 24 weeks | as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum |
| physical performance | after 24 weeks | as assessed by falls, physical performance battery, and 6-min walk test |
Countries
United States
Outcome results
None listed