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A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy

A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy - A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy (SMUIM4-NHL01)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012362
Enrollment
30
Registered
2013-11-21
Start date
2013-11-21
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

Malignant Lymphoma

Interventions

Malignant lymphoma patients with osteoporosis will be administered with 60 mg of denosumab once within one week before the start of prednisolone-containing chemotherapy and with calcium and Vitamin D

Sponsors

Department of Medical Oncology and Hematology, Sapporo Medical University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PS 0-2 Aged ≥20 and ≤90 Patients whose prognosis would be expected more than 3 months Written informed consent

Exclusion criteria

Exclusion criteria: Uncontrolled hepatic disease, renal disease, heart disease, lung disease, diabetes mellitus, hypertention and infectious disease Active concomitant malignancy Severe psychiatric disorders Women who are pregnant or in lactation Hypersensitivity to the denosumab Dental therapy during this trial Current hypocalcemia Patient judged inappropriate for this study by the physicians

Design outcomes

Primary

MeasureTime frame
Change in bone mineral density Change in bone metabolism markers—

Secondary

MeasureTime frame
Incidence rate of pathological bone fracture Adverse events—

Countries

Japan

Contacts

Public ContactTsutomu Sato

Sapporo Medical University Hospital Fourth Department of Internal Medicine

tsutomus@sapmed.ac.jp011-611-2111

Outcome results

None listed

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