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Zoledronic acid as prophylaxis against glucocorticoid-induced osteoporosis in lymphoma

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-527220-27-00
Enrollment
132
Registered
2026-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-07

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

Conditions

Burkitt lymphoma and T-cell lymphomas (The 5th edition of the World Health Organization classification of haematolymphoid tumours: lymphoid neoplasms), follicular lymphoma, Glucocorticoid induced osteoporosis, Large B-cell lymphomas, mantle cell lymphoma, transformations of indolent B-cell lymphomas

Brief summary

The primary endpoint of the study is the fracture rate at 2 years in the completer group, defined as the number of participants with at least one new fracture, who complete follow-up including the two-year follow-up and DXA scan. Fractures are measured as new vertebral fractures on VFA and fractures in any bone registered at follow-up.

Detailed description

• The fracture rate at 2 years, defined as the number of participants (Intention to treat (ITT) group) with at least one new fracture. Fractures are measured as new vertebral fractures on VFA and fractures in any bone registered at follow-up., • Comparison of fracture rates for the completer group, defined as the number of participants with at least one new fracture at the two-year DXA scan and a matched historical comparator group from the Danish lymphoma database., • Change in T-score in the completer group from baseline (initiation of glucocorticoid-containing chemotherapy) to end of study at 2 years, measured by dual-energy X-ray absorptiometry (DXA) scan at the lumbar spine., • Change in T-score in the completer group between baseline (initiation of glucocorticoid-containing chemotherapy) and two year end of study assessment, measured by Dual-energy X-ray absorptiometry (DXA scan) at femoral neck., • Change in T-score in the completer group between baseline (initiation of glucocorticoid-containing chemotherapy) and two year end of study assessment, measured by Dual-energy X-ray absorptiometry (DXA scan) at total hip.

Interventions

DRUGZOLEDRONIC ACID

Sponsors

Region Nordjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is the fracture rate at 2 years in the completer group, defined as the number of participants with at least one new fracture, who complete follow-up including the two-year follow-up and DXA scan. Fractures are measured as new vertebral fractures on VFA and fractures in any bone registered at follow-up.

Secondary

MeasureTime frame
• The fracture rate at 2 years, defined as the number of participants (Intention to treat (ITT) group) with at least one new fracture. Fractures are measured as new vertebral fractures on VFA and fractures in any bone registered at follow-up., • Comparison of fracture rates for the completer group, defined as the number of participants with at least one new fracture at the two-year DXA scan and a matched historical comparator group from the Danish lymphoma database., • Change in T-score in the completer group from baseline (initiation of glucocorticoid-containing chemotherapy) to end of study at 2 years, measured by dual-energy X-ray absorptiometry (DXA) scan at the lumbar spine., • Change in T-score in the completer group between baseline (initiation of glucocorticoid-containing chemotherapy) and two year end of study assessment, measured by Dual-energy X-ray absorptiometry (DXA scan) at femoral neck., • Change in T-score in the completer group between baseline (initiation of glucocor

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 8, 2026