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Zoledronic acid prophylaxis for glucocorticoid‑induced osteoporosis in adult lymphoma patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves patients with several types of blood cancer, including Large B-cell lymphoma, transformations of indolent B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, Burkitt lymphoma and T-cell lymphoma. These cancers are often treated with chemotherapy that contains steroids, which can lead to glucocorticoid‑induced osteoporosis, a condition where the bones become weak and more likely to break. To try to prevent this bone loss, participants receive an infusion of zoledronic acid, a medication that works by slowing down the process that removes bone tissue.

The purpose of the trial is to find out whether the medication is safe and works to protect bone health in this setting. After the first infusion, patients are followed for up to two years with regular check‑ups that include a low‑radiation test called a DXA scan to measure bone density, and they are monitored for any new fracture. The study records whether participants experience bone breaks and how their bone strength changes over time, while also keeping track of any side effects from the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
After joining the study, you will have an initial evaluation that includes a medical history review, blood tests, and a bone density measurement called a dx a scan. the dx a scan uses low‑dose x‑rays to assess the strength of the bones in the spine, hip, and other areas.
These baseline results are used to compare later measurements and to ensure you meet the study criteria.
Step 2
Start of glucocorticoid‑containing chemotherapy
You will begin the chemotherapy regimen that includes glucocorticoid medication. glucocorticoids can weaken bones over time, which is why the study is evaluating a preventive treatment.
Step 3
Zoledronic acid infusion
Shortly after chemotherapy begins, you will receive an intravenous infusion of zoledronic acid. the dose is 5 mg (milligrams) given through a vein over a short period of time.
The infusion is performed by trained staff in a clinical setting. the exact timing follows the study protocol, which may involve a single infusion or additional doses as specified by the investigators.
Step 4
Regular follow‑up visits
Throughout the two‑year study period, you will attend scheduled visits to monitor your health. these visits include checking for side effects, repeating blood tests, and evaluating bone health.
The frequency of visits is defined by the study schedule and may occur every few months.
Step 5
Two‑year bone assessment
At the end of the two‑year period, you will undergo a second dx a scan to measure any changes in bone density.
A fracture assessment will also be performed to determine whether any new bone breaks have occurred during the study.
Step 6
Study completion
After the final assessments, the study data are collected and analyzed. you will be informed about the overall study results, but no further study‑specific procedures are required.

Who can join the trial?

8 criteria

Age 18 or older
Must be able to read and understand the Danish language
Must have been diagnosed with one of the following types of lymphoma: Large B‑cell lymphoma, transformed indolent B‑cell lymphoma, mantle‑cell lymphoma, follicular lymphoma, Burkitt lymphoma, or T‑cell lymphoma, and be scheduled to receive chemotherapy that includes a glucocorticoid (a type of steroid medication used in cancer treatment)
Planned to receive at least six cycles (six rounds) of chemotherapy such as (R‑)CHOP, CHOP, CVP, R‑CVP, mini‑CHOP, R‑mini‑CHOP, CEOP, R‑CEOP, CHOEP, R‑CHOEP, DA‑EPOCH, or R‑DA‑EPOCH, either as first‑line treatment or, for indolent lymphoma, as second‑line treatment when specific timing conditions are met
Must receive a minimum dose of prednisone (or an equivalent steroid) of 60 mg per day during the chemotherapy (for mini‑CHOP, 60 mg given once daily on days 1‑5)
Willing to follow all study‑specific procedures, such as receiving the IV medication and attending scheduled visits
Estimated to have a life expectancy of at least two years
ECOG Performance Status of 0, 1, or 2 (a scale that measures daily functioning; 0 = fully active, 2 = able to do most self‑care but unable to work)

Who cannot join the trial?

11 criteria

If you have any reason you cannot take bisphosphonate medicines (drugs that protect bone), you cannot join the study.
If your general health score, called ECOG Performance status, is higher than 2 (meaning you have more difficulty with daily activities), you cannot join.
If you plan to receive radiation therapy aimed at your hips or lower back, you cannot join.
If you are currently taking medicines that affect bone loss or growth, such as hormone replacement therapy, other bisphosphonates, denosumab, strontium ranelate, selective estrogen receptor modulators (SERMs), estrogen for menopause, teriparatide, or if you are on lithium or anticonvulsant drugs, you cannot join.
If your kidney function measured by eGFR is less than 35 ml/min, you cannot join.
If you have been taking glucocorticoid (steroid) medication for more than four weeks at the time of screening, you cannot join (local estrogen therapy is allowed).
If you are pregnant or breastfeeding, you cannot join.
If you plan to have an autologous stem cell transplantation as part of your treatment, you cannot join.
If you already have a bone fracture caused by lymphoma that is seen on imaging before treatment (a pathological fracture), you cannot join.
If you have had previous lower‑back or hip surgery that makes a bone density scan (DXA) impossible, you cannot join.
If your dental health is poor, requiring invasive dental work or having infections (poor dental status), you cannot join.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Odense University Hospital
Verified
Odense, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Zoledronic acid is a medication given through an IV (intravenous infusion). In this study it is being tested as a preventive treatment to protect the bones of people with lymphoma who are taking steroids. Steroids can make bones weaker, leading to a condition called glucocorticoid‑induced osteoporosis. The trial is checking whether giving zoledronic acid can safely keep the bones strong and reduce the risk of fractures in these patients.

Zoledronic Acid

What is already known about the treatment

Zoledronic Acid - Zoledronic acid is given as an intravenous infusion, usually a single 5 mg dose given over a short period. It is an approved medication that is well documented in medical literature for preventing bone loss in glucocorticoid‑induced osteoporosis and for treating bone problems related to cancer. The drug works by attaching to bone and stopping the cells that break down bone (osteoclasts), which helps keep the skeleton strong. Zoledronic acid is classified as a bisphosphonate.

Investigated diseases

Diffuse large B-cell lymphoma
An aggressive cancer of mature B‑cells that enlarges lymph nodes or forms tumors in other organs. It grows quickly and can spread to the liver, bone marrow, or central nervous system if not controlled.
Transformed indolent B-cell lymphoma
A slow‑growing B‑cell lymphoma that changes into a faster, more aggressive form. The disease accelerates with rapid increase of lymph node size and new organ involvement.
Mantle cell lymphoma
A B‑cell lymphoma that begins in the mantle zone of lymph nodes and often involves the bone marrow, gastrointestinal tract, and blood. It may start slowly but can become more aggressive over time.
Follicular lymphoma
A usually indolent B‑cell lymphoma that forms within lymph node follicles. It can enlarge nodes gradually and may later transform into a faster‑growing lymphoma, occasionally affecting the bone marrow and spleen.
Burkitt lymphoma
A very fast‑growing B‑cell lymphoma that commonly involves the abdomen, jaw, or central nervous system. Cells multiply rapidly, leading to quickly expanding masses that can spread widely.
Peripheral T-cell lymphoma
A group of aggressive cancers arising from mature T‑cells, affecting lymph nodes and often other organs such as skin, liver, or bone marrow. The disease progresses with rapid tumor growth and systemic symptoms.