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Denosumab for Bone Loss Post-HSCT
NCT03925532Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2019
- Primary completion
- Nov 2022
- Countries
- 1
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- denosumab
- Conditions
- osteoporosisosteopenia
01
Overview
Phase 2, open-label, single-arm trial of denosumab in osteoporosis and osteopenia, sponsored by Roswell Park Comprehensive Cancer Center. Primary endpoints: Mean Total Hip Percent Change in Bone Mineral Density (BMD), Slope in Hip Bone Mineral Density Regressed on Time and 2 more. Started Dec 2019; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Supportive Care (denosumab)
Patients receive 2 doses of denosumab SC between days 70-130 and days 250-310 post-HSCT.
03
Who it enrols
Patients who have undergone Allogeneic HSCT with baseline and post-transplant DXA scans, excluding those with hypersensitivity to denosumab, osteonecrosis of the jaw, hypocalcemia risk factors, recent fractures, or severe GVHD/infection.
04
Endpoints
Primary
Mean Total Hip Percent Change in Bone Mineral Density (BMD)
Slope in Hip Bone Mineral Density Regressed on Time
Mean Lumbar Spine Percent Change in Bone Mineral Density (BMD)
Slope in Lumbar Spine Bone Mineral Density Regressed on Time
Secondary
Frequency of Bone Fractures
Number of Participants That Experienced Any Adverse Event
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