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The effects of denosumab compared with alendronate on glucocorticoid-induced osteoporosis in patients with malignant lymphoma

The effects of denosumab compared with alendronate on glucocorticoid-induced osteoporosis in patients with malignant lymphoma - DENOSULY trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038881
Enrollment
100
Registered
2020-01-01
Start date
2020-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glucocorticoid-induced osteoporosis in patients with malignant lymphoma

Interventions

Denosumab group: subcutaneous denosumab 60mg every 6 months and oral calcitriol 0.25ug daily for 1 year since before the start of chemotherapy Alendronate group: oral alendronate 35mg once a week and

Sponsors

Toyama University Hospital Department of Hematology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with newly diagnosed malignant lymphoma Patients older than 65 years Patients who undergo chemotherapy with steroid such as R-CHOP and R-CHOP-like regimen Patients who signed the informed consent form

Exclusion criteria

Exclusion criteria: Patients with a history of hypersensitivity to any component of denosumab Patients with hypocalcemia Patients who are pregnant and who may be pregnant Patients with a condition that makes swallowing difficult such as stenosis and achalasia of esophagus Patients unable to sit upright or stand more than thirty minutes Patients with a history of hypersensitivity to bisphosphonates Patients with hypercalcemia or hypervitaminosis D Patients who are on osteoporotic treatment with denosumab or bisphosphonates Patients thought to be inappropriate for this study by physician

Design outcomes

Primary

MeasureTime frame
Percent change of bone mineral density of the lumbar spine at 12 months after intervention

Countries

Japan

Contacts

Public ContactTsutomu Sato

Toyama University Hospital Department of Hematology

tsutomus@med.u-toyama.ac.jp076-434-7301

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026