Clinical trial · Interventional
A Study of Actonel for the Prevention of Bone Loss
A Randomized, Double Blinded Study of Actonel for the Prevention of Bone Loss in Patients Receiving High Dose Corticosteroids for the Treatment of Acute Lymphocytic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
NCT00452439CI-TRIAL-00049143completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this clinical research study is to learn if Actonel (risedronate) can help to prevent the development of osteoporosis (brittle and weak bones) caused by the steroid medication used to treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Actonel (Risedronate) | Drug | — | UNRESOLVED |
| Calcium | Dietary Supplement | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Actonel
- description
- Actonel (Risedronate) + Vitamin D + Calcium
- interventionNames
- Drug: Actonel (Risedronate)
- Dietary Supplement: Calcium
- Dietary Supplement: Vitamin D
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo + Vitamin D + Calcium
- interventionNames
- Dietary Supplement: Calcium
- Dietary Supplement: Vitamin D
Primary outcomes (2)
- measure
- Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age greater than or equal to 18 years 2. Newly diagnosed ALL or LL receiving chemotherapy with augmented BFM, Hyper-CVAD or any variant of hyper-CVAD. 3. Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception. 4. Negative pregnancy test in female patients. 5. Patients must be enrolled within 6 weeks of starting induction chemotherapy. Exclusion Criteria: 1. Hypocalcemia of less than 8.4 (corrected to account for the albumin level, \[see Appendix E for formula\]) 2. Hypersensitivity to risedronate or other bisphosphonates 3. Inability to sit or stand upright for at least 30 minutes 4. Bone density T-score of -2.5 S.D or less. 5. Renal insufficiency (calculated creatinine clearance \<30cc/min,\[see Appendix F for formula\]) 6. Patients with a 25-hydroxyvitamin D concentration of less than 20 ng/ml and evidence of osteomalacia (low ionized calcium and high intact PTH). 7. Concomitant use of bisphosphonates, calcitonin, anabolic steroids, or fluoride. 8. Corrected calcium above 10.2, due to a cause not related to leukemia/lymphoma (i.e. hyperparathyroidism, multiple myeloma).
References
Publications (0)
Data not yet available
No reference posted for this study.