Zoledronic acid as prophylaxis against glucocorticoid-induced osteoporosis in lymphoma

Condition studied

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

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

• 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.