No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for patients with non-small cell lung cancer and bone metastases. Participants will receive either a specific drug treatment or supportive therapy while their condition is monitored over 3 months.
Are You a Good Fit for This Trial?
Must not be takingZoledronic acidPamidronateAlendronateDenosumab
You may be able to join if
I am between 18 and 100 years old.
I have been diagnosed with non-small cell lung cancer.
I am willing to follow all study procedures.
I can provide signed consent to participate.
I have bone metastases confirmed by imaging.
I have had molecular testing of my cancer.
I have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
I have been prescribed standard care treatment before joining the study.
You may not be able to join if
I have received anti-bone resorptive therapy in the past.
I have another health condition that could affect my safety.
I have received targeted therapy (TKI) for my cancer before this screening.
I have had radiotherapy for my bone metastases unless there has been progression since.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to assess percentage reduction in the of urine NTX and serum CTX , in patients with NSCLC and bone metastases 1) with actionable driver oncogene on standard of care (SOC) TKI at 3 months post treatment and 2) without actionable mutations on standard of care therapy (chemotherapy/immunotherapy) treated with zoledronic acid or denosumab at the same time period.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Provision to sign and date the consent form
2. Stated willingness to comply with all study procedures and be available for the duration of the study
3. Be a male or female aged 18-100 years
4. Pathologically confirmed non-small cell lung cancer
5. Molecular testing through a …
Inclusion Criteria:
1. Provision to sign and date the consent form
2. Stated willingness to comply with all study procedures and be available for the duration of the study
3. Be a male or female aged 18-100 years
4. Pathologically confirmed non-small cell lung cancer
5. Molecular testing through a CLIA-validated NGS assay. This can be done using either tissue based samples or blood-based samples (ctDNA)
6. ECOG PS 0-2
7. Decision to be on a particular standard of care TKI or chemotherapy +/- immunotherapy (clinical decision that would occur prior to study enrollment)
8. Patients who will be treated with an osteoclast inhibitor must receive dental clearance prior to starting treatment
9. Bone metastases must be detected through radiographic imaging prior to enrollment on this study.
Exclusion Criteria:
1. Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy
a. Excluded anti-bone resorptive therapy includes: zolendronic acid, pamidronate, alendronate, denosumab or any medication that acts as an osteoclast inhibitor
2. Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation while on standard of care treatments for the NSCLC.
3. Patients with actionable driver mutation who received TKI in past or currently on TKI prior to screening
4. Bone metastases that have received prior radiotherapy unless unequivocal progression has occurred since radiation therapy
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