A Severity-Adapted Clinical Trial of Diminished Bone Mineral Density in Acute Lymphoblastic Leukemia Survivors

NCT00186901 | Completed Phase 3 Results

• 1 other identifier: BONEII
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 3

Brief Summary

Research studies have shown that children who are long-term survivors of childhood leukemia may be at greater risk for early bone loss called osteoporosis. This bone loss may lead to a greater risk of broken bones and other spine and bone problems. However, researchers still do not know much about how frequently this long-term side effect may occur and how severe the problem is. St. Jude Children's Research Hospital researchers want to determine the frequency and severity of this side effect. They are also studying whether taking calcium and Vitamin D supplements can help children at risk for osteoporosis and if certain factors can be identified -- such as age at diagnosis, cancer treatments, or family history -- that may increase the chances of having osteoporosis. Researchers will take an x-ray study called quantitative computed tomography (QCT) to measure bone mineral density (BMD). The BMD is a measure of bone strength. If a subject's BMD falls below the average, he/she will be assigned to one of two groups. Subjects will be randomly assigned (like tossing a coin) to receive calcium and vitamin D pills. The other half will receive placebo pills that look like the calcium and vitamin D pills.

Conditions

Leukemia, Lymphoblastic, Acute; Osteoporosis

Keywords

Bone Density

Outcome Measures

Primary Outcomes (4)

• Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)

  The effect of taking calcium and vitamin D supplements was measured using Quantitative Computed Tomography (QCT) to calculate a QTC Z score. A standardized Z-score was calculated to indicate the difference between the patient's Bone Mineral Density (BMD) and the mean value for age and gender-appropriate controls. Z-scores from 0 to +2 are considered normal, above +2 are considered to be elevated, from 0 to -1 are considered to represent a mild BMD deficit, between -1 and -2 are considered to represent moderate deficits, and below -2 are considered to represent severe deficits.

  Baseline, 12 months, 24 months, and at 36 months or study end

• Bone Mineral Density in Male and Female ALL Survivors

  Using bone mineral density Z-score, assess relationship between predisposing factors (gender) and bone mineral density; a negative value indicates a deficit in bone mineral density.

  Baseline

• Bone Mineral Density by Race of ALL Survivors

  Using bone mineral density Z-score, assess relationship between predisposing factors (race) and bone mineral density; a negative value indicates a deficit in bone mineral density.

  Baseline

• Bone Mineral Density by Age Group of ALL Survivors

  Using bone mineral density Z-score, assess relationship between predisposing factors (age groups) and bone mineral density; a negative value indicates a deficit in bone mineral density.

  Baseline

Secondary Outcomes (6)

• Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.

  Baseline

• Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.

  12 months

• Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.

  24 months

• Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.

  36 months

• Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype

  At enrollment

Study Arms (2)

1A

PLACEBO COMPARATOR

Nutritional counseling + placebo

Other: Placebo

1B

EXPERIMENTAL

Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period

Drug: Calcium carbonate (Tums), vitamin D

Interventions

Calcium carbonate (Tums), vitamin D DRUG

Calcium carbonate 100mg/day (Tums), vitamin D 800 units/day

1B

Placebo OTHER

Placebo

1A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is a survivor of acute lymphoblastic leukemia.
• Patient was treated on St. Jude Children's Research Hospital's Total XI, XII, or XIII treatment protocol.
• Patient is at least five years out from completion of therapy and is in first remission

You may not qualify if:

• Active disease
• Pregnant or lactating females
• Inability to chew and swallow pills
• Currently taking more than 800 mg supplemental calcium or 800 IU vitamin D
• Anemia

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (3)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Metabolic Bone Center at the University of Tennessee

Memphis, Tennessee, 38163, United States

Location

Preventive Medicine, University of Tennessee

Memphis, Tennessee, 38163, United States

Location

Related Publications (2)

• Kaste SC, Rai SN, Fleming K, McCammon EA, Tylavsky FA, Danish RK, Rose SR, Sitter CD, Pui CH, Hudson MM. Changes in bone mineral density in survivors of childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2006 Jan;46(1):77-87. doi: 10.1002/pbc.20553.

  PMID: 16106430 BACKGROUND

• Crom DB, Tyc VL, Rai SN, Deng X, Hudson MM, Booth A, Rodrigues LN, Zhang L, McCammon E, Kaste SC. Retention of survivors of acute lymphoblastic leukemia in a longitudinal study of bone mineral density. J Child Health Care. 2006 Dec;10(4):337-50. doi: 10.1177/1367493506067886.

  PMID: 17101625 BACKGROUND

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Osteoporosis

Interventions

Calcium Carbonate; Vitamin D

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Sue Kaste, DO
• Organization: St. Jude Children's Research Hospital

referralinfo@stjude.org

866-278-5833

Study Officials

• Sue C. Kaste, D.O.

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2000
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2011
• Last Updated: May 10, 2017
• Results First Posted: March 27, 2012

Record last verified: 2011-12

Locations

US (3)