Phase 3
N=74
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
Non-Hodgkin's Lymphoma · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00352846 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months — 0.08; -0.09 Percentage Change of BMD
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic Acid (Drug); Vitamin D (Drug); Calcium Carbonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months |
0.08; -0.09 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma.
- Prior Chemotherapy /= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3.
- Estimated creatinine clearance >/= 60 ml/min.
- Must sign an informed consent form.
Exclusion Criteria
- Radiologic evidence of vertebral or hip fracture.
- 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.
- Patients with secondary non-lymphomatous cancers metastatic to bone. However, other secondary cancers are allowed.
- Spinal cord compression due to vertebral collapse.
- 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.
- Primary hyperparathyroidism.
- Active osteomalacia.
- Untreated hypocalcemia (ionized, iCa), Ionized Ca level must be within normal limits prior to enrollment.
- Untreated secondary hyperparathyroidism, Patients with abnormal parathyroid hormone (PTH) levels may be enrolled as long as they are being treated.
- Untreated vitamin D deficiency, Vitamin D level may be abnormal and patient may be enrolled as long as they are being treated.
- Untreated low testosterone (test in men only), testosterone level may be abnormal and patient may be enrolled as long as they are being treated.
- Paget's disease.
- Pregnant or breast-feeding.
- Radiotherapy involving the mandible.
- 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.
- Recent (within 3 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).
- Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of 10.2 mg/dL or ionized Ca > 1.32 mmol/L
Data sourced from ClinicalTrials.gov (NCT00352846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.