High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
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 researchers 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 OBJECTIVE: I. 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, patients are randomized to 1 of 2 arms. ARM I: Patients receive HDVD orally (PO) once a week (QW) for 52 weeks. Patients also undergo collection of blood and DXA scan on study. ARM II: Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of blood
- Dietary SupplementD Vitamin
Given PO
- ProcedureDual X-ray Absorptiometry
Undergo DXA scan
- DrugPlacebo Administration
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Reduction of bone mineral density (BMD) loss as measured at the total hip
Will determine the efficacy of high-dose vitamin D (HDVD) supplementation versus placebo in reducing BMD loss as measured at the total hip via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of covariance (ANCOVA) with group (vitamin D or placebo) as the main factor, baseline timepoint (\[T\]1) BMD as covariate, and week 52 (T3) 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.
Time frame: At 52 weeks
Reduction of BMD loss as measured at the femoral neck
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the femoral neck via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) 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.
Time frame: At 52 weeks
Reduction of BMD loss as measured at the distal radius
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the distal radius via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) 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.
Time frame: At 52 weeks
Reduction of BMD loss as measured at the lumbar spine
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the lumbar spine via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) 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.
Time frame: At 52 weeks
Secondary
Change in falls
Time frame: Baseline up to 52 weeks
Change in fractures
Time frame: Baseline up to 52 weeks
Change in quality of life
Time frame: Baseline up to 52 weeks
Eligibility criteria
Study locations (51)
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Carle Cancer Center
Urbana, Illinois, 61801
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Mercy Hospital
Coon Rapids, Minnesota, 55433
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
Ridgeview Medical Center
Waconia, Minnesota, 55387
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
CarolinaEast Medical Center
New Bern, North Carolina, 28561
Nash UNC HealthCare
Rocky Mount, North Carolina, 27804
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Community Medical Center
Scranton, Pennsylvania, 18510
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Saint Francis Hospital
Greenville, South Carolina, 29601
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, 37604
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
Ballad Health Cancer Care - Bristol
Bristol, Virginia, 24201
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495