OsteoporosisPhase 3NCT01656512
Zometa Study in Pediatric Acute Lymphoblastic Leukemia
A Phase 3 study testing zolendronic acid and calcium & vitamin D in people with Osteoporosis, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial summary
Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers \& 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- zolendronic acid and calcium & vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2011to Aug 2015
- Phase
- Phase 3
- 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
Who may be able to join
- Age above 5 \& below 18 years at the time of diagnosis.
- Newly diagnosed ALL patients.
- Not previously treated, previous steroid intake not more than 72 hours.
- Treated according to St Judy study XV protocol.
Who cannot join
- Previous steroid intake more than 72 hours.
- Less than 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers \& 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year after treatment (Journal Of Clinical Endocrinology \& Metabolism 2009). The investigators will study the role of bisphosphonates in the prevention of secondary osteoporosis in children \& adolescents treated for ALL in the Children's Cancer Hospital -Egypt.
- Conditions
- Osteoporosis
- Being tested
- zolendronic acid, calcium & vitamin D
- Keywords
- ALL, zoledronic acid, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolendronic acidDrug
Also called bisphosphonates
patients will receive calcium \& vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of
- Initial dose: (0.025) mg /kg
- Subsequent doses ( 0.05) mg /kg.
- Maximum dose of 4 mg.
calcium & vitamin DDrug
patients will receive calcium \& vitamin D Dose of Calcium : 1500- 2000 gram elemental Calcium daily . Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit
| Study group | Role | What they receive |
|---|---|---|
| Arm ( A) | Active comparator | Arm ( A) : patients will receive calcium \& vitamin D Receives: Drug: calcium & vitamin D |
| Arm (B) | Experimental | we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of Receives: Drug: zolendronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the change in the Bone densitometry due to secondary osteoporosis
we will do the following for evaluation :
- Bone densitometry using Dual-energy x-ray absorptiometry (DXA) scan analyzed using the Z-score. To be done :
- At baseline ( not more than 48 hours of start of therapy with steroids)
- At week 48
- At end of treatment ( week 120 for girls ) \& ( week 146 for boys)
- As required clinically eg: fractures .
- Magnetic resonance imaging of both hips \& knees will be done at reinduction I \& II \& if symptomatic.
Measured: 1- At baseline ( not more than 48 hours of start of therapy with steroids) 2- At week 48 3- At end of treatment ( week 120 for girls ) & ( week 146 for boys) 4-As required clinically eg: fractures .
Secondary outcomes (1)
- To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.
Measured: week 48 continuation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shimaa Samir, MBBCH, Principal investigator, Children's Cancer Hospital Egypt 57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656512
- Sponsor's protocol ID
- CCHE-ALL002
- Status last verified
- Apr 2018
- First submitted
- 30 Jul 2012
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
- ClinicalTrials.gov ID
- NCT01656512
- Acronym / sponsor ID
- CCHE-ALL002
- Conditions
- Osteoporosis
- Keywords
- ALL, zoledronic acid, Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Aug 2012 (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.
Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers \& 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year after treatment (Journal Of Clinical Endocrinology \& Metabolism 2009). The investigators will study the role of bisphosphonates in the prevention of secondary osteoporosis in children \& adolescents treated for ALL in the Children's Cancer Hospital -Egypt.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm ( A) | Active comparator | Drug: calcium & vitamin DArm ( A) : patients will receive calcium \& vitamin D |
| Arm (B) | Experimental | Drug: zolendronic acidwe will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age above 5 \& below 18 years at the time of diagnosis.
- Newly diagnosed ALL patients.
- Not previously treated, previous steroid intake not more than 72 hours.
- Treated according to St Judy study XV protocol.
Key exclusion criteria (2 listed)
- Previous steroid intake more than 72 hours.
- Less than 5 years
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 |
|---|---|---|
| zolendronic acidAlso: bisphosphonatespatients will receive calcium \& vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of 1. Initial dose: (0.025) mg /kg 2. Subsequent doses ( 0.05) mg /kg. 3. Maximum dose of 4 mg. | Drug | Arm (B) |
| calcium & vitamin Dpatients will receive calcium \& vitamin D Dose of Calcium : 1500- 2000 gram elemental Calcium daily . Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit | Drug | Arm ( A) |
Primary outcome
Measure the change in the Bone densitometry due to secondary osteoporosis
Time frame: 1- At baseline ( not more than 48 hours of start of therapy with steroids) 2- At week 48 3- At end of treatment ( week 120 for girls ) & ( week 146 for boys) 4-As required clinically eg: fractures .
we will do the following for evaluation : 1. Bone densitometry using Dual-energy x-ray absorptiometry (DXA) scan analyzed using the Z-score. To be done : * At baseline ( not more than 48 hours of start of therapy with steroids) * At week 48 * At end of treatment ( week 120 for girls ) \& ( week 146 for boys) * As required clinically eg: fractures . 2. Magnetic resonance imaging of both hips \& knees will be done at reinduction I \& II \& if symptomatic.
1 secondary outcome
- To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.
Time frame: week 48 continuation phase
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 17 Apr 2018.
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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.
Shimaa Samir, MBBCH principal investigator
Children's Cancer Hospital Egypt 57357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zolendronic acid and calcium & vitamin D in people with Osteoporosis, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
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 4 inclusion and 2 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 17 Apr 2018. 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 Egypt. 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.
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?
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.
What does the primary outcome measure?
Measure the change in the Bone densitometry due to secondary osteoporosis (time frame: 1- At baseline ( not more than 48 hours of start of therapy with steroids) 2- At week 48 3- At end of treatment ( week 120 for girls ) & ( week 146 for boys) 4-As required clinically eg: fractures .). It is what the study was designed to measure, not a finding.
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 17 Apr 2018.