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Vitamin D and Physical Activity on Bone Health

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Luke Peppone, University of Rochester
ClinicalTrials.gov Identifier:
NCT01419730
First received: August 11, 2011
Last updated: March 4, 2014
Last verified: March 2014

August 11, 2011
March 4, 2014
August 2011
February 2015   (final data collection date for primary outcome measure)
Measure the amount of bone loss in non-metastatic breast cancer patients receiving a high dose vitamin D therapy along with a structured home-based walking and progressive resistance exercise program. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone metabolism biomarkers in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months.

To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone mineral density (BMD) as measured by a dual energy X-ray absorptiometry (DXA) in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months.

Measure the amount of bone loss in non-metastatic breast cancer patients receiving a high dose vitamin D therapy along with a structured home-based walking and progressive resistance exercise program. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone metabolism biomarkers in non-metastatic breast cancer patients who began hormonal therapy within the previous 6 months.

To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone mineral density (BMD) as measured by a dual energy X-ray absorptiometry (DXA) in non-metastatic breast cancer patients who began hormonal therapy within the previous 6 months.

Complete list of historical versions of study NCT01419730 on ClinicalTrials.gov Archive Site
Measure the effect of vitamin D and exercise on physical fitness in non-metastatic breast cancer patients [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Measuring physical fitness includes balance, aerobic capacity, and muscle strength in non-metastatic breast cancer patients who begin hormonal therapy within the previous 12 months.
Measure the effect of vitamin D and exercise on physical fitness in non-metastatic breast cancer patients [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Measuring physical fitness includes balance, aerobic capacity, and muscle strength in non-metastatic breast cancer patients who begin hormonal therapy withing the previous 6 months.
Not Provided
Not Provided
 
Vitamin D and Physical Activity on Bone Health
The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy

This research will examine the effectiveness of vitamin D or placebo (the placebo is a tablet that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with and without physical activity (walking and progressive resistance exercise), in treating bone loss in women who have undergone treatment for breast cancer. The investigators would also like to find out if the physical activity program improves cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and balance. One hundred five (105) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Bone Metabolism Biomarkers
  • Bone Mineral Density
  • Physical Fitness
  • Drug: Vitamin D3
    Vitamin D3 50,000 IU
  • Behavioral: Physical Activity
    Progressive walking and resistance band exercise prescription for a period of 24 weeks
  • Active Comparator: Vitamin D3 50,000 IU
    Vitamin D3 50,000 IU: Patients will be assigned to receive a daily multivitamin, calcium supplement and 50,000 IU/week of vitamin D for a period of 24 weeks.
    Intervention: Drug: Vitamin D3
  • Active Comparator: Vitamin D3 50,000 IU and Physical Activity
    Vitamin D3 50,000 IU and Physical Activity: Patients will be assigned to receive a daily multivitamin, calcium supplement, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.
    Interventions:
    • Drug: Vitamin D3
    • Behavioral: Physical Activity
  • No Intervention: Control
    Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
105
December 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be female and have a primary diagnosis of Stage I, II, or III hormone-receptor positive breast cancer.
  • Women must be postmenopausal at time of enrollment.
  • Must provide informed consent.
  • Must be willing to discontinue use of calcium and/or vitamin D supplements.
  • Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.6 mg/dl.
  • Participants must be slightly vitamin D deficient (serum vitamin D level <32ng/ml)
  • Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.132
  • Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 24-week supplementation of vitamin D.
  • Must be less than five years from the diagnosis of breast cancer and must be within 12 months of starting treatment with aromatase inhibitors (AI) in accordance with American Society of Clinical Oncology (ASCO) guidelines.

Exclusion Criteria:

  • Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease.
  • Patients who had a myocardial infarction within the past year.
  • Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
  • Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
  • Patients with hypercalcemia (corrected serum Ca ≥ 10.6 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
  • Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.
  • Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.
  • Patients with a known sensitivity to vitamin D.
  • Patients who are severely vitamin D deficient (<10 ng/ml).
  • Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.
  • Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.
  • Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).
Female
18 Years and older
No
Contact: Jennifer Reschke, MS 585-275-0690 jennifer_reschke@urmc.rochester.edu
United States
 
NCT01419730
34834
Yes
Luke Peppone, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Luke J Peppone, PhD, MPH University of Rochester
University of Rochester
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP