Observationeel onderzoek naar botcomplicaties bij mensen met postmenopauzale borstkanker die zijn gestopt met de behandeling met denosumab en aromataseremmers
Postmenopauzale borstkankerpatiënten behandeld met aromataseremmers en denosumab: een observatieonderzoek om reboundbotverlies en insufficiëntiefracturen te beoordelen na stopzetting van denosumab
The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor/AI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Monica Fornier, MD
- Telefoonnummer: 646-888-4563
- E-mail: fornierm@mskcc.org
Studie Contact Back-up
- Naam: Azeez Farooki, MD
- Telefoonnummer: 646-608-3798
- E-mail: farookia@mskcc.org
Studie Locaties
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New Jersey
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Basking Ridge, New Jersey, Verenigde Staten, 07920
- Werving
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Contact:
- Monica Fornier, MD
- Telefoonnummer: 646-888-4563
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Middletown, New Jersey, Verenigde Staten, 07748
- Werving
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Contact:
- Monica Fornier, MD
- Telefoonnummer: 646-888-4563
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Montvale, New Jersey, Verenigde Staten, 07645
- Werving
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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Contact:
- Monica Fornier, MD
- Telefoonnummer: 646-888-4563
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New York
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Commack, New York, Verenigde Staten, 11725
- Werving
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
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Contact:
- Monica Fornier, MD
- Telefoonnummer: 646-888-4563
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Harrison, New York, Verenigde Staten, 10604
- Werving
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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Contact:
- Monica Fornier, MD
- Telefoonnummer: 646-888-4563
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New York, New York, Verenigde Staten, 10065
- Werving
- Memorial Sloan Kettering Cancer Center
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Contact:
- Monica Fornier, MD
- Telefoonnummer: 646-888-5240
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Uniondale, New York, Verenigde Staten, 11553
- Werving
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Contact:
- Monica Fornier, MD
- Telefoonnummer: 646-888-4563
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Patients will be recruited through the Breast Medicine and Survivorship Services. Members of the research team will verify eligibility against the patient's medical record. Once eligibility is confirmed, and if the treating investigator has no objection to enrolling the patient in the research study, the patient will be approached for consent. Consent to the protocol will be conducted by a trained consenting professional. Consent will take place either in the clinic, or by following the most updated standard working procedures for consent via telemedicine.
Beschrijving
Inclusion Criteria:
- Women with Stage 0-3 breast cancer confirmed at MSKCC
- Currently have no clinical evidence of disease
- Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment
- Received at least 2 doses of denosumab and then discontinued therapy
- Discontinued AI prior to or within 6 months of last denosumab injection
- Patients must be 18 years of age or olde
Exclusion Criteria:
- Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan;
- Patients with history of insufficiency fracture.
- Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab
- Patients on chronic low-dose glucosteroids.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Post- menopausal breast cancer patients
Participants are post- menopausal with a breast cancer diagnosis who received at least 2 doses of denosumab, and then discontinued therapy, and discontinued Aromatase Inhibitors/AI prior to or within 6 months of stopping denosumab |
Participants will be assessed at Timepoint 0 (last dose of denosumab injection) and then at 9,12,18 and 24 months following discontinuation of denosumab. The evaluation will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work for bone turnover markers (including serum carboxy-terminal collagen crosslinks (CTX) in serum and bone specific alkaline phosphatase). Bone turn-over markers should be drawn in the morning, after at least 8 hours of fasting (water, black coffee and plain tea allowed). Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint.
Andere namen:
TBS is an innovative gray-level texture measurement that utilizes lumbar spine DEXA images to discriminate changes in bone microarchitecture. Specifically, TBS measures bone quality through tridimensional bone areas with different trabecular and microstructural characteristics. The combination of TBS microstructure evaluation with bone density measured by DEXA has been shown to be superior to either measurement alone in the assessment of fracture risk.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in serum carboxy-terminal collagen crosslinks (CTX)
Tijdsspanne: 12 months
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Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - serum carboxy-terminal collagen crosslinks (CTX) |
12 months
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Change in bone specific alkaline phosphatase (ALK)
Tijdsspanne: 12 months
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Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - bone specific alkaline phosphatase (ALK) |
12 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Monica Fornier, MD, Memorial Sloan Kettering Cancer Center
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 22-280
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Informatie over medicijnen en apparaten, studiedocumenten
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