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Vitamin D and Physical Activity on Bone Health

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from University of Rochester

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Results first posted: Aug 5, 2026
    • Secondary endpoints: 1 to 3
    v22
  2. Study completion date: Dec 30, 2025 to Dec 30, 2026v21
  3. Primary completion date: Apr 30, 2024 to Dec 30, 2024
    • Study completion date: Mar 30, 2025 to Dec 30, 2025
    v20
  4. Primary completion date changed from estimate of Sep 30, 2023 to Apr 30, 2024
    • Study completion date: Sep 30, 2023 to Mar 30, 2025
    v19
  5. Primary and study completion dates: Sep 30, 2022 to Sep 30, 2023v18
Show 16 earlier versionsHide 16 earlier versions
  1. Primary and study completion dates: Sep 30, 2021 to Sep 30, 2022v17
  2. Primary and study completion dates: Jun 30, 2021 to Sep 30, 2021v16
  3. Primary completion date: Jun 2019 to Jun 30, 2021
    • Trial status: Completed to Active, Not Recruiting
    • Study completion date: May 2020 to Jun 30, 2021
    v15
  4. Study completion date: Jun 2019 to May 2020v14
  5. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 105 to confirmed 191
    v13
  6. Primary completion date: Feb 2019 to Jun 2019v12
  7. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2018 to Feb 2019
    • Site details revised
    v11
  8. Primary completion date: Jan 2018 to Dec 2018
    • Study completion date: Jun 2018 to Jun 2019
    v10
  9. Primary completion date: Jun 2016 to Jan 2018
    • Study completion date: Dec 2016 to Jun 2018
    v9
  10. 2 versions Re-verified since Oct 22, 2015, no change to tracked fieldsv7-v8
  11. Primary completion date: Feb 2015 to Jun 2016
    • Study completion date: Dec 2015 to Dec 2016
    v6
  12. Re-verified, no change to tracked fieldsv5
  13. Phase: Not applicable to Phase 2v4 Show 8 more changesShow less
    • Enrollment target: 40 to 105
    • Primary completion date: Feb 2014 to Feb 2015
    • Study completion date: Dec 2015
    • Interventions: Home-Based Exercise (Behavioral), Vitamin D3 (Drug) to Physical Activity (Behavioral), Vitamin D3 (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated
    • Study arms: 4 to 3
    • Eligibility criteria expanded, about 5 words
  14. Primary completion date: Feb 2013 to Feb 2014v3
  15. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Feb 2012 to Feb 2013
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01419730
Lead Sponsor University of Rochester
Conditions
(from sponsor)		 Bone Metabolism Biomarkers, Bone Mineral Density, Physical Fitness
Enrollment 191 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov