Observationsundersøgelse af knoglekomplikationer hos mennesker med postmenopausal brystkræft, der er stoppet med behandling med denosumab og aromatasehæmmere
Postmenopausale brystkræftpatienter behandlet med aromatasehæmmere og Denosumab: En observationsundersøgelse til at vurdere rebound-knogletab og insufficiensfrakturer efter seponering af 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Monica Fornier, MD
- Telefonnummer: 646-888-4563
- E-mail: fornierm@mskcc.org
Undersøgelse Kontakt Backup
- Navn: Azeez Farooki, MD
- Telefonnummer: 646-608-3798
- E-mail: farookia@mskcc.org
Studiesteder
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New Jersey
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Basking Ridge, New Jersey, Forenede Stater, 07920
- Rekruttering
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Kontakt:
- Monica Fornier, MD
- Telefonnummer: 646-888-4563
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Middletown, New Jersey, Forenede Stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Kontakt:
- Monica Fornier, MD
- Telefonnummer: 646-888-4563
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Montvale, New Jersey, Forenede Stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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Kontakt:
- Monica Fornier, MD
- Telefonnummer: 646-888-4563
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New York
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Commack, New York, Forenede Stater, 11725
- Rekruttering
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
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Kontakt:
- Monica Fornier, MD
- Telefonnummer: 646-888-4563
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Harrison, New York, Forenede Stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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Kontakt:
- Monica Fornier, MD
- Telefonnummer: 646-888-4563
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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Kontakt:
- Monica Fornier, MD
- Telefonnummer: 646-888-5240
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Uniondale, New York, Forenede Stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Kontakt:
- Monica Fornier, MD
- Telefonnummer: 646-888-4563
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
Andre navne:
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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in serum carboxy-terminal collagen crosslinks (CTX)
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Monica Fornier, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 22-280
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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