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A Study of Actonel for the Prevention of Bone Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00452439
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Drug: Actonel (Risedronate) Dietary Supplement: Calcium Dietary Supplement: Vitamin D Phase 3

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).

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2004
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014


Arm Intervention/treatment
Active Comparator: Actonel
Actonel (Risedronate) + Vitamin D + Calcium
Drug: Actonel (Risedronate)
35 mg (pill) by mouth weekly
Other Name: Risedronate Sodium

Dietary Supplement: Calcium
500 mg by mouth twice a day for a total of 24 months.

Dietary Supplement: Vitamin D
400 IU by mouth twice a day for a total of 24 months.

Placebo Comparator: Placebo
Placebo + Vitamin D + Calcium
Dietary Supplement: Calcium
500 mg by mouth twice a day for a total of 24 months.

Dietary Supplement: Vitamin D
400 IU by mouth twice a day for a total of 24 months.




Primary Outcome Measures :
  1. Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months [ Time Frame: 6 months ]
    bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months.

  2. Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months [ Time Frame: 12 months ]
    bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 12 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452439


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Procter and Gamble
Investigators
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Principal Investigator: Maria E. Cabanillas, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00452439    
Other Study ID Numbers: ID03-0124
NCI-2010-01997 ( Registry Identifier: NCI CTRP )
First Posted: March 27, 2007    Key Record Dates
Results First Posted: December 28, 2020
Last Update Posted: December 28, 2020
Last Verified: December 2020
Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Lymphoma
Acute Lymphocytic Leukemia
Lymphoblastic Lymphoma
Actonel
Risedronate
Bone Loss
Osteoporosis
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vitamin D
Risedronic Acid
Etidronic Acid
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action