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Monoclonal Antibodies

Denosumab for Osteopenia

Phase 2
Waitlist Available
Led By Philip L McCarthy
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-hsct
Awards & highlights

Study Summary

This trial tests the side effects of denosumab and how well it works in treating patients with bone loss after a stem cell transplant.

Eligible Conditions
  • Osteopenia
  • Osteoporosis
  • Hematopoietic Stem Cell Transplant Recipient

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post-hsct
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-hsct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Lumbar Spine Percent Change in Bone Mineral Density (BMD)
Mean Total Hip Percent Change in Bone Mineral Density (BMD)
Slope in Hip Bone Mineral Density (g/cm^2 Per Day) Regressed on Time in Dual
+1 more
Secondary outcome measures
Frequency of Bone Fractures
Mean Lumbar Spine Percent Change in BMD
Number of Participants That Experienced Any AE

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256
44%
joint pain
22%
nausea
22%
propagation of fracture at biopsy site
11%
dizziness
11%
rhinorrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab Only
Teriparatide Only
Denosumab and Teriparatide

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (denosumab)Experimental Treatment1 Intervention
Patients receive 2 doses of denosumab SC between days 70-130 and days 250-310 after allogeneic hematopoietic stem cell transplant in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2017
Completed Phase 4
~12500

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,828 Total Patients Enrolled
AmgenIndustry Sponsor
1,369 Previous Clinical Trials
1,377,516 Total Patients Enrolled
Philip L McCarthyPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
460 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently accepting participants?

"According to information hosted on clinicaltrials.gov, this research project has ceased recruitment for the time being; having been initially posted in December 2019 and last updated in October 2022. Notwithstanding, 210 other studies are actively enrolling participants at present."

Answered by AI

What medical conditions is Denosumab typically prescribed to address?

"Denosumab is a popular therapy for bone-related issues and has been used to treat mature skeletal systems, the effects of hormones like testosterone, as well as various types of cancer."

Answered by AI

Are there any precedents that demonstrate the efficacy of Denosumab in clinical settings?

"In 2016, Xavier Nogues conducted the first ever study on denosumab. Since its inception, there have been 112 studies completed and 48 live trials occuring in various locations such as Buffalo, New york."

Answered by AI

What assessments have been done to ascertain the security of Denosumab for humans?

"Given that this is a Phase 2 trial, our team at Power has concluded that Denosumab displays an acceptable degree of safety and thus gave it a score of 2. Moreover, due to the nature of Phase 2 trials there is data demonstrating its security but no evidence showcasing its efficacy yet."

Answered by AI

How many participants are being evaluated in this clinical investigation?

"This clinical trial is no longer seeking participants. Initially posted on December 19th 2019, it was last modified October 20th 2022. Currently, 162 trials are recruiting patients with osteoporosis and 48 more studies enlisting Denosumab users can be found online."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant
2019. "Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03925532.
~6 spots leftby Apr 2025
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