Leukemia, Lymphoblastic, AcutePhase 3NCT00186901

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

A Phase 3 study testing Calcium carbonate (Tums), vitamin D in people with Leukemia, Lymphoblastic, Acute and Osteoporosis, run by St. Jude Children's Research Hospital at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Leukemia, Lymphoblastic, Acute, Osteoporosis
What is being tested?: Calcium carbonate (Tums), vitamin D
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 429 participants
Where: 3 sitesUnited States
Study dates: Jul 2000to Sep 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Metabolic Bone Center at the University of Tennessee
Memphis, Tennessee, 38163
Preventive Medicine, University of Tennessee
Memphis, Tennessee, 38163

Other trials in United States

About this study

Official title: Diminished Bone Mineral Density in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL): A Severity-Adapted Clinical Trial

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.

Read the detailed description

The main objectives of the study are:

To estimate, using quantitative computed tomography (QCT), the prevalence of diminished bone mineral density (BMD) in patients treated with contemporary, protocol-based multiagent chemotherapy (+cranial irradiation) for childhood acute lymphoblastic leukemia (ALL).
To investigate possible risk factors for the development of diminished BMD in patients treated with contemporary protocol-based therapy for childhood ALL. Factors to be examined include patient characteristics (age at the time of treatment, gender, race, body mass index, physical activity and nutritional status, menarchal status, oral contraceptive use, growth hormone therapy, smoking and alcohol intake, birth weight, fracture history); treatment effects (intensity of treatment with antimetabolites and glucocorticoids; history of cranial irradiation); and genetic predisposition (i.e., vitamin D and CYP3A4 receptor polymorphism and family history of osteoporosis).
To evaluate, in a prospective placebo-controlled double-blinded randomized trial, the effects of vitamin D and calcium supplementation in addition to nutritional counseling on BMD in patients with BMD scores below the mean for age- and gender-matched controls, compared to an educational program of nutritional counseling alone.

Secondary Aim

To evaluate, in a prospective randomized trial, the correlation between BMD as determined by QCT and BMD as determined by dual energy x-ray absorptiometry (DEXA) in patients with BMD more than one standard deviation (SD) below the mean for age- and gender-matched controls.

Conditions: Leukemia, Lymphoblastic, Acute, Osteoporosis
Being tested: Calcium carbonate (Tums), vitamin D, Placebo
Keywords: Bone Density
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00186901
Study group	Role	What they receive
1A	Placebo comparator	Nutritional counseling + placebo Receives: Other: Placebo
1B	Experimental	Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period Receives: Drug: Calcium carbonate (Tums), vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline

Secondary outcomes (6)

Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.
To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 121 patients at baseline were assessed by both method the QCT and DXA methods to assess Bone Mineral Density.
Measured: Baseline
Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.
To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 218 patients were assessed at 12 months for QCT. 94 were evaluated using DXA. 94 patients received both scans.
Measured: 12 months
Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.
To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 188 patients were assessed at 24 months by the QCT method and 90 were evaluated using the DXA methods to assess Bone Mineral Density. 90 patients received both scans.
Measured: 24 months
Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.
To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 180 patients were assessed at 36 months by the QCT method and 89 were evaluated using the DXA methods to assess Bone Mineral Density. 89 patients received both scans.
Measured: 36 months
Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype
The Apa1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood
Measured: At enrollment
Mean QCT Z-Score by Bsm 1 Vitamin D Receptor Genotype
The Bsm1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood
Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2000Sep 2011

First posted16 Sep 2005 (estimated)
Study startJul 2000
Primary completionJun 2009
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Leukemia, Lymphoblastic, AcuteStudies of the same condition, open and under way.
More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 429 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00186901
Sponsor's protocol ID: BONEII
Status last verified: Dec 2011
First submitted: 12 Sep 2005
Last updated: 10 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 16106430
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.
PubMed 17101625

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

All Leukemia, Lymphoblastic, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diminished Bone Mineral Density in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL): A Severity-Adapted Clinical Trial
ClinicalTrials.gov ID: NCT00186901
Acronym / sponsor ID: BONEII
Conditions: Leukemia, Lymphoblastic, Acute, Osteoporosis
Keywords: Bone Density
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 429 participants (actual)
Lead sponsor: St. Jude Children's Research HospitalUniversity, hospital or other
Study start: Jul 2000
Primary completion: Jun 2009 (actual)
Study completion: Sep 2011 (actual)
First posted: 16 Sep 2005 (estimated)
Results: Posted 27 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The main objectives of the study are:

To estimate, using quantitative computed tomography (QCT), the prevalence of diminished bone mineral density (BMD) in patients treated with contemporary, protocol-based multiagent chemotherapy (+cranial irradiation) for childhood acute lymphoblastic leukemia (ALL).
To investigate possible risk factors for the development of diminished BMD in patients treated with contemporary protocol-based therapy for childhood ALL. Factors to be examined include patient characteristics (age at the time of treatment, gender, race, body mass index, physical activity and nutritional status, menarchal status, oral contraceptive use, growth hormone therapy, smoking and alcohol intake, birth weight, fracture history); treatment effects (intensity of treatment with antimetabolites and glucocorticoids; history of cranial irradiation); and genetic predisposition (i.e., vitamin D and CYP3A4 receptor polymorphism and family history of osteoporosis).
To evaluate, in a prospective placebo-controlled double-blinded randomized trial, the effects of vitamin D and calcium supplementation in addition to nutritional counseling on BMD in patients with BMD scores below the mean for age- and gender-matched controls, compared to an educational program of nutritional counseling alone.

Secondary Aim

To evaluate, in a prospective randomized trial, the correlation between BMD as determined by QCT and BMD as determined by dual energy x-ray absorptiometry (DEXA) in patients with BMD more than one standard deviation (SD) below the mean for age- and gender-matched controls.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1A	Placebo comparator	Other: PlaceboNutritional counseling + placebo
1B	Experimental	Drug: Calcium carbonate (Tums), vitamin DNutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calcium carbonate (Tums), vitamin DCalcium carbonate 100mg/day (Tums), vitamin D 800 units/day	Drug	1B
PlaceboPlacebo	Other	1A

Primary outcome

Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)
Time frame: Baseline, 12 months, 24 months, and at 36 months or study end
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.
Bone Mineral Density in Male and Female ALL Survivors
Time frame: Baseline
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.
Bone Mineral Density by Race of ALL Survivors
Time frame: Baseline
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.
Bone Mineral Density by Age Group of ALL Survivors
Time frame: Baseline
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.

6 secondary outcomes

Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.
Time frame: Baseline
Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.
Time frame: 12 months
Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.
Time frame: 24 months
Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.
Time frame: 36 months
Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype
Time frame: At enrollment
Mean QCT Z-Score by Bsm 1 Vitamin D Receptor Genotype
Time frame: At enrollment

Results and safety

Results posted to the registry on 27 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Group	134	85
Supplement Group	141	96
Patients Ineligible for Randomization	149	0

Primary outcome: Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)

Time frame: Baseline, 12 months, 24 months, and at 36 months or study end. Median (Full Range). Unit: Z-Score

Measure	Placebo n = 134	Supplement n = 141
Baseline	-0.95 (-3.09 to -0.05)	-0.97 (-3.94 to -0.04)
12 Months	-0.87 (-3.23 to 0.85)	-1.04 (-4.32 to 0.58)
24 Months	-0.72 (-2.61 to 0.91)	-0.76 (-3.75 to 1.23)
36 Months (study end)	-0.56 (-2.96 to 1.36)	-0.61 (-4.23 to 2.02)

Placebo vs Supplement: Median Difference (Final Values): -0.02, p = 0.86, Wilcoxon Test
Placebo vs Supplement: Median Difference (Final Values): -0.17, p = 0.99, Wilcoxon Test
Placebo vs Supplement: Median Difference (Final Values): -0.04, p = 0.54, Wilcoxon Test

Population analysed: Of the 275 pts identified with BMD z-scores \< 0, 134 were randomized to the placebo group and 141 to the supplement group. Bone Mineral Density QCT Z-scores were calculated at baseline, 12 months, 24 months, and at 36 months or study end.

Primary outcome: Bone Mineral Density in Male and Female ALL Survivors

Time frame: Baseline. Median (Standard Error). Unit: Z-score

Measure	Male n = 218	Female n = 206
Value	-0.62 (1.18)	-0.3 (1.18)

Male vs Female: Median Difference (Final Values): -0.32, p = 0.0004, Wilcoxon (Mann-Whitney)

Population analysed: Baseline participants were assessed to determine whether gender was a pre-disposing factor for bone mineral density.

Primary outcome: Bone Mineral Density by Race of ALL Survivors

Time frame: Baseline. Median (Standard Error). Unit: Z-score

Measure	White n = 365	Non-white n = 59
Value	-0.54 (1.14)	0.15 (1.56)

White vs Non-white: Median Difference (Final Values): -0.69, p = 0.0023, Wilcoxon (Mann-Whitney)

Population analysed: Assess baseline participants to determine whether race contributed to bone mineral density.

Primary outcome: Bone Mineral Density by Age Group of ALL Survivors

Time frame: Baseline. Median (Standard Error). Unit: Z-score

Measure	9 to 13 Years n = 98	13 to 18 Years n = 139	18 to 22 Years n = 74	Above 22 Years n = 113
Value	-0.6 (1.1)	-0.54 (1.21)	-0.59 (1.2)	-0.25 (1.29)

9 to 13 Years vs 13 to 18 Years vs 18 to 22 Years vs Above 22 Years: p = 0.0092, Kruskal-Wallis

Population analysed: Assess baseline participants to determine whether age was a contributing factor in bone mineral density.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were assessed for adverse events from August, 2000 through July, 2006.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Group	0 of 134 (0%)	0 of 134 (0%)	Not reported
Supplement Group	0 of 141 (0%)	0 of 141 (0%)	Not reported
Patients Ineligible for Randomization	0 of 149 (0%)	0 of 149 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16106430Kaste 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.
Background: PubMed 17101625Crom 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.
St. Jude Children's Research HospitalLink provided by the sponsor.

Related trials for Leukemia, Lymphoblastic, Acute

Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sue C. Kaste, D.O. principal investigator

St. Jude Children's Research Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcium carbonate (Tums), vitamin D in people with Leukemia, Lymphoblastic, Acute and Osteoporosis, run by St. Jude Children's Research Hospital at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD) (time frame: Baseline, 12 months, 24 months, and at 36 months or study end). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00186901, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.