Status:
COMPLETED
A Study of Actonel for the Prevention of Bone Loss
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Procter and Gamble
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 trea...
Detailed Description
One of the side effects of using high dose corticosteroids for the treatment of ALL is osteoporosis. Risedronate is a medication that was designed to help prevent osteoporosis (brittle and weak bones)...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years
- Newly diagnosed ALL or LL receiving chemotherapy with augmented BFM, Hyper-CVAD or any variant of hyper-CVAD.
- Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.
- Negative pregnancy test in female patients.
- Patients must be enrolled within 6 weeks of starting induction chemotherapy.
Exclusion
- Hypocalcemia of less than 8.4 (corrected to account for the albumin level, \[see Appendix E for formula\])
- Hypersensitivity to risedronate or other bisphosphonates
- Inability to sit or stand upright for at least 30 minutes
- Bone density T-score of -2.5 S.D or less.
- Renal insufficiency (calculated creatinine clearance \<30cc/min,\[see Appendix F for formula\])
- Patients with a 25-hydroxyvitamin D concentration of less than 20 ng/ml and evidence of osteomalacia (low ionized calcium and high intact PTH).
- Concomitant use of bisphosphonates, calcitonin, anabolic steroids, or fluoride.
- Corrected calcium above 10.2, due to a cause not related to leukemia/lymphoma (i.e. hyperparathyroidism, multiple myeloma).
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00452439
Start Date
February 1 2004
End Date
August 1 2014
Last Update
December 28 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030