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OsteonecrosisNCT01104324

Osteonecrosis in Children With Acute Lymphoblastic Leukemia

An observational study of Osteonecrosis and Acute Lymphoblastic Leukemia, run by Halton, Jacqueline, M.D. at 10 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Osteonecrosis, Acute Lymphoblastic Leukemia
How many people
130 participants
Where
10 sitesCanada
Study dates
Jul 2009to Dec 2012
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 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients with Acute lymphoblastic leukemia who have participated in the STOPP - CIS study will be eligible for this ancillary study.

Who may be able to join

  • Enrollment in the STOPP-CIS study
  • Informed consent of patient or care givers
  • >5 years of age at MRI assessment

Who cannot join

  • Individuals with a history of claustrophobia precluding MRI assessment

Trial locations and contacts

10 sites in 1 country.

Jacqueline Halton contact

613 737 7600 ext. 2978

Lynda Hoey contact

613 737 7600 ext. 4109

10 sites in 1 country

Canada10 sites, 10 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta

    Julie Hamilton, 403 955 7641

    Victor Lewis, MD

    Not yet recruiting

  • Stollery Children's Hospital

    Edmonton, Alberta

    Linda Churcher, 780 407 8790

    Bev Wilson, MD

    Not yet recruiting

  • IWK Health Centre

    Halifax, Nova Scotia

    Alesha Warner, 902 470-7414

    Beth Cummings, MD

    Not yet recruiting

  • Children's Hospital of Western Ontario

    London, Ontario

    Martha Rolland

    Beth Cairney, MD

    Not yet recruiting

  • Hopital Sainte-Justine

    Montreal, Quebec

    Claude Belleville, (514) 345-4931 ext. 2579

    Nathalie Alos, MD

    Not yet recruiting

  • Montreal Children's Hospital

    Montreal, Quebec

    Diane Laforte, (514) 412-4400 ext. 22521

    Celia Rodd, MD

    Not yet recruiting

  • Childrens Hospital of Eastern Ontario

    Ottawa, Ontario

    MacLennan, 613 737 7600

    Jacqueline Halton, MD

    Recruiting

  • Hospital for Sick Children

    Toronto, Ontario

    Ron Grant

    Not yet recruiting

  • BC Children's Hospital

    Vancouver, British Columbia

    Terry Viczko, 604 875 2345 ext. 5312

    David Dix, MD

    Not yet recruiting

  • Winnipeg Children's Hospital

    Winnipeg, Manitoba

    Dan Catte, 204 977 5645

    Sara Israels, MD

    Not yet recruiting

Other trials in Canada

About this study

Official title: Steroid Induced Osteoporosis in the Pediatric Population Ancillary Study- Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.

Keywords
bone health, Osteonecrosis, acute lymphoblastic leukemia
Medical subject headings
Osteonecrosis, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What is being measured

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

  1. osteonecrosis 1 year post leukemia therapy

    Each participant will undergo MRI of hip, knee, ankle and shoulder to look for ON

    Measured: One year after completion of therapy for leukemia

Secondary outcomes (8)

  1. Bone mass density and Osteonecrosis

    Is reductions in bone mass density at diagnosis of leukemia associated with the development of ON. These patients are a subset of a lagre study where Bone mass is being measured by DEXA. We will be able to access this data to look for bone mass density

    Measured: One year post therapy for leukemia

  2. Is Bone loss/failure to accure bone mineral and ON

    Is bone loss/failure to accrue bone mineral at a normal rate during chemotherapy is/are associated with the development of ON.These patients are a subset of a lagre study where Bone mass is being measured by DEXA. We will be able to access this data to look for bone loss

    Measured: One year post leukemia therapy

  3. Glucocorticoid dose and ON

    Is there a glucocorticoid threshold dose, above which patients are more likely to develop ON. These patients are a subset of a lagre study where glucocorticoid dose is recorded. We will be able to access this data.

    Measured: One year post Leukemia therapy

  4. Methotrexate dose and ON

    Is there a methotrexate threshold dose, above which patients are more likely to develop ON. These patients are a subset of a lagre study where Methotrexate dose is recorded. We will be able to access this data.

    Measured: One year post leukemia therpy

  5. Obesity and ON

    Is obesity either at diagnosis or during therapy associated with ON. These patients are a subset of a larger group in a larger study. They are recording height weight and BMI. We will be able to access this data.

    Measured: One year post leukemia therapy

  6. Weight bearing and non weight bearing activities and ON

    Does weight bearing and non-weight bearing activities play a role in the development of ON. These patients are a subset of a larger study. They are recording these activities. We will be able to use this data.

    Measured: One year post leukrmia therapy

  7. Hyperlipidemia and On

    Is hyperlipidemia associated with the development of ON. Statins (cholesterol lowering medications) have been suggested as a therapeutic intervention to prevent ON. Fasting blood will be tested for lipids at at least one year post chemtherapy.

    Measured: One year post leukemia therapy

  8. Thrombophilia and ON

    Is thrombophilia associated with the development of ON. Blood will be tested at study entry following one year completion of chemotherapy.Blood will be drawn for protein C, protein S, antithrombin, activated protein C resistance, Factor V Leiden, prothrombin gene complex, MTHFR, lupus anticoagulant and antiphospholipid antibodies and Lipoprotein A.

    Measured: One year post leukemia therapy

Timeline

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

  1. First posted15 Apr 2010 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01104324
Sponsor's protocol ID
08/20E
Status last verified
Apr 2010
First submitted
12 Apr 2010
Last updated
15 Apr 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteonecrosis and Acute Lymphoblastic Leukemia, run by Halton, Jacqueline, M.D. at 10 sites in Canada.

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 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada. 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?

Results are not available in the source record.

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

Contact Jacqueline Halton (613 737 7600 ext. 2978), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

osteonecrosis 1 year post leukemia therapy (time frame: One year after completion of therapy for leukemia). 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 NCT01104324.

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 15 Apr 2010.

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