A Study of Actonel for the Prevention of Bone Loss - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Procter and Gamble
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00452439

Purpose

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	Intervention	Phase
Leukemia Lymphoma	Drug: Actonel (Risedronate) Dietary Supplement: Calcium Dietary Supplement: Vitamin D	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Calcium Cancer Chronic Lymphocytic Leukemia Leukemia Lymphoma Osteoporosis Vitamin D

Drug Information available for: Risedronic acid Risedronate sodium Calcium gluconate Vitamin D

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Bone Mineral Density (BMD) [ Time Frame: Baseline followed each 6 months to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	February 2004
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452439

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Procter and Gamble

Investigators

Principal Investigator:

Maria E. Cabanillas, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00452439 History of Changes
Other Study ID Numbers:	ID03-0124
Study First Received:	March 23, 2007
Last Updated:	December 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Leukemia
Lymphoma
Acute Lymphocytic Leukemia
Lymphoblastic Lymphoma

Actonel
Risedronate
Bone Loss
Osteoporosis

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Risedronic acid
Vitamin D
Ergocalciferols

Etidronic Acid
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012