Zoledronic acid as prophylaxis against glucocorticoid-induced osteoporosis in lymphoma

Prior treatment

• Planned radiation therapy against hips and/or lower back region (columna lumbalis).
• On treatment with antiresorptive or anabolic medications including hormone replacement therapy (such as bisphosphonates, denosumab, strontium ranelate, selective estrogen receptor modulators (SERMs), estrogen used to treat symptoms associated with female menopause, teriparatide), received ongoing lithium or anticonvulsants treatment.
• Glucocorticoid treatment for more than four weeks at the time of screening start. (Local estrogen therapy (e.g., estradiol vaginal inserts) is permitted regardless of duration)
• Planned autologous stem cell transplantation consolidation.
• Patients diagnosed with a pathological fracture at baseline related to lymphoma (as assessed on baseline routine pre-therapy imaging with CT or PET/CT).
• Previous lower back surgery or hip surgery making DXA impossible to assess.

Other illness

• Poor dental status (need of invasive dental procedures and/or infections) on inspection by study physician.

Lab values

• eGFR <35ml/min (screening blood tests or in blood tests obtained up till 3 weeks before screening if available)

Other

• Contraindications to bisphosphonates.
• Patients with an ECOG Performance status >2.
• Pregnant and lactating women.

• Age ≥18.
• Capable of reading and understanding Danish language.
• Diagnosed with Large B-cell lymphomas, transformations of indolent B-cell lymphomas, mantle cell lymphoma, follicular lymphoma, Burkitt lymphoma and T-cell lymphomas planned for treatment with a glucocorticoid-containing chemotherapy regimen (The 5th edition of the World Health Organization classification of haematolymphoid tumours: lymphoid neoplasms)
• Planned for ≥6 cycles of treatment with (Rituximab), Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-)CHOP), CHOP, CVP, R-CVP, mini-CHOP, R-mini-CHOP, CEOP, R-CEOP, CHOEP, R-CHOEP, DA-EPOCH, R-DA-EPOCH) in 1st line with exception of patients with indolent lymphoma, who may also receive the listed treatments in 2nd line, if more than 24 months have passed between first lymphoma diagnosis and 2nd line treatment and if none of the above treatments were given as 1 st line treatment. Rituximab is however, being part of many treatment regimens, allowed for both 1st Line and 2nd line treatment. Minimum dose of prednisone (or equivalent) must be 60mg/day (ex. for mini-CHOP 60mgx1 for day 1-5). Patients who are planned to receive central nervous system prophylaxis or radiation therapy in addition to (R-)CHOP (-like) chemotherapy are also eligible.
• Willingness to comply with protocol specific procedures.
• Minimum estimated life expectancy for participants 2 year.
• ECOG Performance status 0-2.