A Study of Actonel for the Prevention of Bone Loss

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Procter and Gamble
• Treatments: Calcium; Calcium, Dietary; Ergocalciferols; Etidronic Acid; Risedronate Sodium; Risedronic Acid; Vitamin D; Vitamins

Criteria

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).