Breast CancerNCT05590949
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical Evaluation, Dual-energy X-ray absorptiometry scans and Trabecular Bone Score
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Oct 2022to 18 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Monica Fornier, MD, 646-888-4563
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, 11725
Monica Fornier, MD, 646-888-4563
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Monica Fornier, MD, 646-888-4563
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Monica Fornier, MD, 646-888-4563
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Monica Fornier, MD, 646-888-4563
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Monica Fornier, MD, 646-888-5240
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Monica Fornier, MD, 646-888-4563
About this study
Official title: Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation
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.
- Conditions
- Breast Cancer
- Being tested
- Physical Evaluation, Dual-energy X-ray absorptiometry scans, Trabecular Bone Score
- Keywords
- Post-menopausal Breast Cancer, Breast Cancer, Denosumab, Aromatase, 22-280, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical EvaluationOther
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 scansDiagnostic test
Also called DEXA scans
Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint.
Trabecular Bone ScoreDiagnostic test
Also called TBS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Physical Evaluation; Diagnostic Test: Dual-energy X-ray absorptiometry scans; Diagnostic Test: Trabecular Bone Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum carboxy-terminal collagen crosslinks (CTX)
Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - serum carboxy-terminal collagen crosslinks (CTX)
Measured: 12 months
Change in bone specific alkaline phosphatase (ALK)
Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - bone specific alkaline phosphatase (ALK)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start18 Oct 2022
- Primary completion18 Oct 2027 (estimated)
- Study completion18 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Fornier, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590949
- Sponsor's protocol ID
- 22-280
- Status last verified
- Nov 2026
- First submitted
- 18 Oct 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation
- ClinicalTrials.gov ID
- NCT05590949
- Acronym / sponsor ID
- 22-280
- Conditions
- Breast Cancer
- Keywords
- Post-menopausal Breast Cancer, Breast Cancer, Denosumab, Aromatase, 22-280, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 18 Oct 2027 (estimated)
- Study completion
- 18 Oct 2027 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post- menopausal breast cancer patients | – | Other: Physical Evaluation, Diagnostic Test: Dual-energy X-ray absorptiometry scans, Diagnostic Test: Trabecular Bone ScoreParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical EvaluationParticipants 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). | Other | Post- menopausal breast cancer patients |
| Dual-energy X-ray absorptiometry scansAlso: DEXA scansDual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint. | Diagnostic test | Post- menopausal breast cancer patients |
| Trabecular Bone ScoreAlso: TBSTBS 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. | Diagnostic test | Post- menopausal breast cancer patients |
Primary outcome
Change in serum carboxy-terminal collagen crosslinks (CTX)
Time frame: 12 months
Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - serum carboxy-terminal collagen crosslinks (CTX)
Change in bone specific alkaline phosphatase (ALK)
Time frame: 12 months
Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - bone specific alkaline phosphatase (ALK)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica Fornier, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Fornier, MD (646-888-4563, fornierm@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum carboxy-terminal collagen crosslinks (CTX) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.