Clinical trial · Interventional
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss in Non-Hodgkin's Lymphoma Patients Receiving Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: * Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck. Secondary Objectives: * Evaluate the effect of zoledronate on change in BMD at the total hip * Evaluate risk factors for developing osteoporosis on chemotherapy * Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium Carbonate | Drug | — | UNRESOLVED |
| Vitamin D | Drug | — | UNRESOLVED |
| Zoledronic Acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D + Calcium Carbonate
- description
- Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
- interventionNames
- Drug: Vitamin D
- Drug: Calcium Carbonate
- type
- EXPERIMENTAL
- label
- Vitamin D + Calcium Carbonate + Zoledronic Acid
- description
- Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m\^2 intravenous at baseline and 6 months.
- interventionNames
- Drug: Zoledronic Acid
- Drug: Vitamin D
- Drug: Calcium Carbonate
Primary outcomes (1)
- measure
- Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma. 2. Prior Chemotherapy\</= 4 weeks of treatment. 3. Age \>/= 18 years old. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3. 5. Estimated creatinine clearance \>/= 60 ml/min. 6. Must sign an informed consent form. Exclusion Criteria: 1. Radiologic evidence of vertebral or hip fracture. 2. BMD T-score less than (i.e., worse than or more negative than) -2.0 at any of the following sites: lumbar spine, femoral neck, or total hip. 3. Patients with secondary non-lymphomatous cancers metastatic to bone. However, other secondary cancers are allowed. 4. Spinal cord compression due to vertebral collapse. 5. Bisphosphonate treatment in the prior 6 months or steroid use (greater than 35 mg of prednisone equivalent steroids) in the prior 3 months. The use of topical, inhaled, or nasal steroids is allowed. 6. Primary hyperparathyroidism. 7. Active osteomalacia. 8. Untreated hypocalcemia (ionized, iCa), Ionized Ca level must be within normal limits prior to enrollment. 9. Untreated secondary hyperparathyroidism, Patients with abnormal parathyroid hormone (PTH) levels may be enrolled as long as they are being treated. 10. Untreated vitamin D deficiency, Vitamin D level may be abnormal and patient may be enrolled as long as they are being treated. 11. Untreated low testosterone (test in men only), testosterone level may be abnormal and patient may be enrolled as long as they are being treated. 12. Paget's disease. 13. Pregnant or breast-feeding. 14. Radiotherapy involving the mandible. 15. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), or of exposed bone in the mouth, or of slow healing after dental procedures. 16. Recent (within 3 weeks) or planned dental or jaw surgery (e.g.. extraction, implants). 17. Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of \< 60 mL/minute. 18. Known hypersensitivity to zoledronic acid or other bisphosphonates. 19. Hypercalcemia: corrected Ca \> 10.2 mg/dL or ionized Ca \> 1.32 mmol/L
References
Publications (1)
- DERIVEDWestin JR, Thompson MA, Cataldo VD, Fayad LE, Fowler N, Fanale MA, Neelapu S, Samaniego F, Romaguera J, Shah J, McLaughlin P, Pro B, Kwak LW, Sanjorjo P, Murphy WA, Jimenez C, Toth B, Dong W, Hagemeister FB. Zoledronic acid for prevention of bone loss in patients receiving primary therapy for lymphomas: a prospective, randomized controlled phase III trial. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):99-105. doi: 10.1016/j.clml.2012.11.002. Epub 2012 Dec 29. PMID 23276888