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L'essai clinique NCT01419730 pour Bone Metabolism Biomarkers, Densité minérale osseuse, Condition physique est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Vitamin D and Physical Activity on Bone Health

Actif, pas en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT01419730 est conçu pour étudier le treatment de Bone Metabolism Biomarkers, Densité minérale osseuse, Condition physique. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : actif, pas en recrutement. L'essai a débuté le 1 août 2011 et vise à recruter 191 participants. Dirigé par l'Université de Rochester, l'essai devrait être terminé d'ici le 30 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 4 juin 2025.
Résumé succinct
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.
Titre officiel

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

Conditions
Bone Metabolism BiomarkersDensité minérale osseuseCondition physique
Autres identifiants de l'essai
  • 34834
Numéro NCT
NCT01419730
Date de début (réel)
2011-08
Dernière mise à jour publiée
2025-06-04
Date de fin (estimée)
2025-12-30
Inscription (estimée)
191
Type d'essai
Interventionnel
PHASE
Phase II
Statut
Actif, pas en recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Factoriel
Masquage
Double aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifVitamin 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
Comparateur actifVitamin 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
Activité physique
Progressive walking and resistance band exercise prescription for a period of 24 weeks
Aucune interventionControl
Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.
N/A
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme
  • 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 logoUniversité de Rochester192 essais cliniques actifs à explorer
Partie responsable de l'essai
Luke Peppone, Investigateur principal, Assistant Professor, University of Rochester
Aucune donnée de contact disponible
1 Centres de l'essai dans 1 pays

New York

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