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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)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma

Thank you

Trial Information

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)


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).

Before treatment you will receive a complete physical exam. You will have around 1
tablespoon of blood drawn for blood tests (these tests are in addition to the routine blood
tests you will have as part of the treatment for leukemia). You will have a urine sample
collected for routine tests. You will also have a bone mineral density test. This test
measures the density of the bones in your spine, hip, and total body. The test is similar
to having x-rays of your bones taken.

You will be randomly assigned (as in the toss of a coin) to one of two treatment groups.
Participants in the first group will be given risedronate (once per week), vitamin D (once
per day), and calcium (once per day). All three medications are pills and will be taken by
mouth. Participants in the second group will be given placebo (once per week), vitamin D
(once per day), and calcium (once per day). All three medications are pills and will be
taken by mouth. A placebo is a substance that looks like the study drug but has no active
ingredients. Neither you nor your doctor will know to which group you are assigned.
However, if it is needed for your care, the information will be given to your doctor.

Participants in both groups will continue to receive chemotherapy during this study as
scheduled. During chemotherapy, you will have around 1 tablespoon of blood drawn every 1-2
weeks for routine blood tests (as part of the standard of care for your treatment of
leukemia).

For this study, you will have urine samples collected and repeat bone mineral density tests
6 months, 12 months, 18 months, and 24 months after starting the study drug (or placebo).

If you develop intolerable side effects from the risedronate you will be taken off the
study.

This is an investigational study. Risedronate is FDA approved and commercially available.
Up to 80 eligible patients will take part in this study. All will be enrolled at M. D.
Anderson.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Bone Mineral Density (BMD)

Outcome Time Frame:

Baseline followed each 6 months to 24 months

Safety Issue:

No

Principal Investigator

Maria E. Cabanillas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID03-0124

NCT ID:

NCT00452439

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Leukemia
  • Lymphoma
  • Acute Lymphocytic Leukemia
  • Lymphoblastic Lymphoma
  • Actonel
  • Risedronate
  • Bone Loss
  • Osteoporosis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030