Leukemia, Lymphocytic, Acute, L1NCT00330538
Osteoporosis in Children With ALL
An observational study of Leukemia, Lymphocytic, Acute, L1, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Hypothesis: Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as a part of the leukemia treatment protocol, will have an increased incidence and severity of osteoporosis. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Leukemia, Lymphocytic, Acute, L1
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Oct 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric patients with a new diagnosis of ALL between ages 4-18
- Patients who are expected to receive glucocorticoids as part of the leukemia treatment protocol
- Bone density measurements must be performed at the diagnosis visit or maximally within 48 hours after the first dose of glucocorticoids
Who cannot join
- Patients under 4 years of age are excluded due to lack of age appropriate standards for bone mineral density
- Glucocorticoid therapy of at least one month or longer within the six months prior to DX
- History of connective tissue or musculoskeletal disorders
- Biphosphonate therapy within the past 6 months
- Acute renal failure
- Serum creatinine equal to or higher than 4.5mg/dl
- Positive serum pregnancy test in adolescent females
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy
Hypothesis:
Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as a part of the leukemia treatment protocol, will have an increased incidence and severity of osteoporosis.
Read the detailed description
Osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration of bone tissue. Osteoporosis is a devastating disorder with significant physical, psychosocial and financial consequences. Intensive chemotherapy and radiotherapy have led to significant improvements in long term, disease-free survival of children with malignancies. Unfortunately, there are many deleterious side effects associated with this therapy. Little is known about the longitudinal changes in bone mass accumulation and bone metabolism in these patients.
The purpose of this study is to evaluate the timing and severity of changes in bone mineral metabolism for children treated for childhood leukemia. Data will be used to establish treatment protocols with the goal of preventing severe fractures and pain in the acute treatment stage and severe osteoporosis and related pathology in the chronic stage.
- Conditions
- Leukemia, Lymphocytic, Acute, L1
- Keywords
- Osteoporosis, Childhood acute lymphoblastic leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Osteoporosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startMar 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Acute, L1Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Jadranka Popovic, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330538
- Sponsor's protocol ID
- 03 08-085
- Status last verified
- Apr 2007
- First submitted
- 26 May 2006
- Last updated
- 6 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy
- ClinicalTrials.gov ID
- NCT00330538
- Acronym / sponsor ID
- 03 08-085
- Conditions
- Leukemia, Lymphocytic, Acute, L1
- Keywords
- Osteoporosis, Childhood acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 29 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis:
Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as a part of the leukemia treatment protocol, will have an increased incidence and severity of osteoporosis.
Detailed description
Osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration of bone tissue. Osteoporosis is a devastating disorder with significant physical, psychosocial and financial consequences. Intensive chemotherapy and radiotherapy have led to significant improvements in long term, disease-free survival of children with malignancies. Unfortunately, there are many deleterious side effects associated with this therapy. Little is known about the longitudinal changes in bone mass accumulation and bone metabolism in these patients.
The purpose of this study is to evaluate the timing and severity of changes in bone mineral metabolism for children treated for childhood leukemia. Data will be used to establish treatment protocols with the goal of preventing severe fractures and pain in the acute treatment stage and severe osteoporosis and related pathology in the chronic stage.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All pediatric patients with a new diagnosis of ALL between ages 4-18
- Patients who are expected to receive glucocorticoids as part of the leukemia treatment protocol
- Bone density measurements must be performed at the diagnosis visit or maximally within 48 hours after the first dose of glucocorticoids
Key exclusion criteria (7 listed)
- Patients under 4 years of age are excluded due to lack of age appropriate standards for bone mineral density
- Glucocorticoid therapy of at least one month or longer within the six months prior to DX
- History of connective tissue or musculoskeletal disorders
- Biphosphonate therapy within the past 6 months
- Acute renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2007.
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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.
Jadranka Popovic, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphocytic, Acute, L1, run by Children's Mercy Hospital Kansas City at 1 site 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 7 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 6 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 6 Apr 2007.