- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00904423
Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption
A Phase I/II Randomized, Double-blind, Controlled Study to Evaluate Efficacy and Safety of Vitamin D on Bone Mineral Density and Markers of Bone Resorption in Aromatase Inhibitor-induced Bone Loss in Women With Breast Cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
-
-
California
-
Stanford, California, Förenta staterna, 94305
- Stanford University School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
3.1.1 All postmenopausal women with histology-confirmed invasive primary breast cancer, who have completed primary surgical or radiotherapy (XRT) with or without adjuvant chemotherapy and are candidates to receive adjuvant therapy with aromatase inhibitors will be screened for eligibility. Postmenopausal is defined as satisfying one or more of the following criteria: having had bilateral oophorectomy; aged more than 60 years; or aged 55-59 years with an intact uterus and amenorrheic for at least 12 months; or if amenorrheic for less than 12 months (after receiving hysterectomy, hormone therapy or chemotherapy).
3.1.2 At the time of study enrollment, participants will have completed primary surgical or XRT with or without adjuvant chemotherapy. Chemotherapy will be completed at least 28 days prior to enrollment.
3.1.4 Participants will be women between 18-85 years of age. Women and minorities will be actively recruited. Though breast cancer extremely rarely occurs in children and men, this study will only recruit adult females.
3.1.5 Participants will have a life expectancy of at least 5 years.
3.1.6 Participants will have Eastern Clinical Oncology Group (ECOG) performance status 0-2.
3.1.7 Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
3.2.1 Medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use > 5 mg/day prednisone or equivalent, teriparatide).
3.2.2 Use of any investigational drug within past 90 days.
3.2.3 Metastatic breast cancer. High risk for osteoporosis/fractures (BMD < -2.0, history of non-traumatic fracture). Hyperparathyroidism Hypercalcemia Hypercalciuria (fasting spot urine calcium/creatinine ratio >0.20) History of renal stones Renal failure with creatinine over 2.0
3.2.4 Considering that vitamin D3 is produced by the human body, allergy to vitamin D3 is not expected to develop. Subjects with known history of allergic reaction to compounds used to manufacture capsules (rice powder) will be excluded form this study.
3.2.5 Recent history of excessive alcohol or drug use.
3.2.6 As this study will recruit post-menopausal patients, thus pregnant or nursing patients are not part of this investigation.
3.2.8 This study is designed to study women after completing primary therapy for breast cancer. Survivors of previous cancers and HIV-positive subjects will not be excluded.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Vitamin D
|
up to 2400 mg; oral tablet
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Spine Bone Mineral Density T Score Change Over One Year
Tidsram: 1 year
|
1 year
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in Hip Bone Mineral Density (BMD) T-score
Tidsram: one year
|
one year
|
Bone Turnover Markers
Tidsram: months 4 and 12
|
months 4 and 12
|
Arthralgias and Myalgias
Tidsram: every 4 months
|
every 4 months
|
Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio
Tidsram: every 4 months
|
every 4 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Eva Balint, Stanford University
- Huvudutredare: Robert W Carlson, Stanford University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-15005
- SU-09232008-1302 (Annan identifierare: Stanford University)
- BRSADJ0014 (Annan identifierare: OnCore)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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