bèta
Trial Radar AI
De klinische studie NCT01419730 voor Bone Metabolism Biomarkers, Botmineraaldichtheid, Lichamelijke fitheid is actief, niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
Eén studie komt overeen met de filtercriteria
Kaartweergave
Terug naar zoekresultaten

Vitamin D and Physical Activity on Bone Health

Actief, niet rekruterend
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT01419730 onderzoekt behandeling bij Bone Metabolism Biomarkers, Botmineraaldichtheid, Lichamelijke fitheid. Deze Fase 2 interventioneel-studie heeft de status actief, niet rekruterend. Het doel is om 191 deelnemers te includeren vanaf 1 augustus 2011. De studie wordt geleid door de Universiteit van Rochester en de voltooiing is gepland op 30 december 2025. Laatste update op ClinicalTrials.gov: 4 juni 2025.
Beknopte samenvatting
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.
Officiële titel

The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy

Aandoeningen
Bone Metabolism BiomarkersBotmineraaldichtheidLichamelijke fitheid
Andere studie-ID's
  • 34834
NCT-ID
NCT01419730
Startdatum (Werkelijk)
2011-08
Laatste update geplaatst
2025-06-04
Verwachte einddatum
2025-12-30
Inschrijving (Geschat)
191
Studietype
Interventioneel
FASE
Fase 2
Status
Actief, niet rekruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Factorieel
Blindering
Dubbelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Actieve comparatorVitamin 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.
Vitamine D3
Vitamin D3 50,000 IU
Actieve comparatorVitamin 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.
Vitamine D3
Vitamin D3 50,000 IU
Lichamelijke activiteit
Progressive walking and resistance band exercise prescription for a period of 24 weeks
Geen interventieControl
Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.
N.v.t.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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.
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.
24 weeks
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Measure the effect of vitamin D and exercise on physical fitness in non-metastatic breast cancer patients
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.
24 weeks
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
  • 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.

  • 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).
University of Rochester logoUniversiteit van Rochester194 actieve klinische studies om te verkennen
Verantwoordelijke instantie
Luke Peppone, Hoofdonderzoeker, Assistant Professor, University of Rochester
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen

New York

University of Rochester, Rochester, New York, 14642, United States