Phase 2
N=30
Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant
Allogeneic Hematopoietic Stem Cell Transplantation Recipient · Osteopenia · Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT03925532 ↗Enrolled (actual)
30
Serious AEs
16.7%
Results posted
Mar 2024
Primary outcome: Primary: Mean Total Hip Percent Change in Bone Mineral Density (BMD) — -4.28 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Denosumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Total Hip Percent Change in Bone Mineral Density (BMD) |
-7.61 | — |
| PRIMARY Slope in Hip Bone Mineral Density (g/cm^2 Per Day) Regressed on Time in Dual |
0.04026 | — |
| PRIMARY Mean Lumbar Spine Percent Change in Bone Mineral Density (BMD) |
0.77 | — |
| PRIMARY Mean Total Hip Percent Change in Bone Mineral Density (BMD) |
-7.61 | — |
| PRIMARY Slope in Lumbar Spine Bone Mineral Density (g/cm^2 Per Day) Regressed on Time in Dual |
-0.09690 | — |
| SECONDARY Mean Lumbar Spine Percent Change in BMD |
-4.04 | — |
| SECONDARY Frequency of Bone Fractures |
— | — |
| SECONDARY Number of Participants That Experienced Any AE |
7 | — |
Summary
This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.
Eligibility Criteria
Inclusion Criteria
- The patient has undergone an Allogeneic Hematopoietic Stem Cell Transplant
- The patient has completed a base line dual x-ray absorptiometry (DXA) scan =< 6 months prior to transplantation
- The patient has completed a post-transplant DXA scan at day 100 (+/- 30 days) or up to 6 months post transplantation
- The patient has completed and passed a dental clearance exam up to 6 months prior to transplant or 6 months after transplant
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
- The patient has a history of a hypersensitivity reaction to denosumab
- The patient has a history of osteonecrosis of the jaw
- The patient has predisposing risk factors for hypocalcemia including the following:
- Hypoparathyroidism
- Creatinine clearance (CrCl) < 30 mL/min
- Dialysis
- Malabsorption syndrome
- The patient has history of any bone fracture =< 30 days prior to denosumab therapy
- Pregnant or nursing female patients.
- The patient has clinically significant GVHD leading to hospitalization at the time of denosumab dose per prescriber discretion.
- The patient has clinically significant infection leading to hospitalization at the time of denosumab dose (excluding hospitalization due to complexity of treatment leading to inability to treat outpatient, ie. Foscarnet) per prescriber discretion
- The patient is unwilling or unable to follow protocol requirements
- The patient has any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug including relapsed malignancy
Data sourced from ClinicalTrials.gov (NCT03925532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.