LeukemiaPhase 3NCT00452439
A Study of Actonel for the Prevention of Bone Loss
A Phase 3 study testing Actonel (Risedronate), Calcium and Vitamin D in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if Actonel (risedronate) can help to prevent the development of osteoporosis (brittle and weak bones) caused by the steroid medication used to treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Actonel (Risedronate), Calcium and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Aug 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Newly diagnosed ALL or LL receiving chemotherapy with augmented BFM, Hyper-CVAD or any variant of hyper-CVAD.
- Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.
- Negative pregnancy test in female patients.
- Patients must be enrolled within 6 weeks of starting induction chemotherapy.
Who cannot join
- Hypocalcemia of less than 8.4 (corrected to account for the albumin level, [see Appendix E for formula])
- Hypersensitivity to risedronate or other bisphosphonates
- Inability to sit or stand upright for at least 30 minutes
- Bone density T-score of -2.5 S.D or less.
- Renal insufficiency (calculated creatinine clearance <30cc/min,[see Appendix F for formula])
- Patients with a 25-hydroxyvitamin D concentration of less than 20 ng/ml and evidence of osteomalacia (low ionized calcium and high intact PTH).
- Concomitant use of bisphosphonates, calcitonin, anabolic steroids, or fluoride.
- Corrected calcium above 10.2, due to a cause not related to leukemia/lymphoma (i.e. hyperparathyroidism, multiple myeloma).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized, Double Blinded Study of Actonel for the Prevention of Bone Loss in Patients Receiving High Dose Corticosteroids for the Treatment of Acute Lymphocytic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
The goal of this clinical research study is to learn if Actonel (risedronate) can help to prevent the development of osteoporosis (brittle and weak bones) caused by the steroid medication used to treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied.
Read the detailed description
One of the side effects of using high dose corticosteroids for the treatment of ALL is osteoporosis. Risedronate is a medication that was designed to help prevent osteoporosis (brittle and weak bones).
Before treatment you will receive a complete physical exam. You will have around 1 tablespoon of blood drawn for blood tests (these tests are in addition to the routine blood tests you will have as part of the treatment for leukemia). You will have a urine sample collected for routine tests. You will also have a bone mineral density test. This test measures the density of the bones in your spine, hip, and total body. The test is similar to having x-rays of your bones taken.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in the first group will be given risedronate (once per week), vitamin D (once per day), and calcium (once per day). All three medications are pills and will be taken by mouth. Participants in the second group will be given placebo (once per week), vitamin D (once per day), and calcium (once per day). All three medications are pills and will be taken by mouth. A placebo is a substance that looks like the study drug but has no active ingredients. Neither you nor your doctor will know to which group you are assigned. However, if it is needed for your care, the information will be given to your doctor.
Participants in both groups will continue to receive chemotherapy during this study as scheduled. During chemotherapy, you will have around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests (as part of the standard of care for your treatment of leukemia).
For this study, you will have urine samples collected and repeat bone mineral density tests 6 months, 12 months, 18 months, and 24 months after starting the study drug (or placebo).
If you develop intolerable side effects from the risedronate you will be taken off the study.
This is an investigational study. Risedronate is FDA approved and commercially available. Up to 80 eligible patients will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Actonel (Risedronate), Calcium, Vitamin D
- Keywords
- Leukemia, Lymphoma, Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, Actonel, Risedronate, Bone Loss, Osteoporosis
- Medical subject headings
- Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actonel (Risedronate)Drug
Also called Risedronate Sodium
35 mg (pill) by mouth weekly
CalciumDietary supplement
500 mg by mouth twice a day for a total of 24 months.
Vitamin DDietary supplement
400 IU by mouth twice a day for a total of 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Actonel | Active comparator | Actonel (Risedronate) + Vitamin D + Calcium Receives: Drug: Actonel (Risedronate); Dietary Supplement: Calcium; Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Placebo + Vitamin D + Calcium Receives: Dietary Supplement: Calcium; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months
bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months.
Measured: 6 months
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months
bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startFeb 2004
- Primary completionAug 2014
- Study completionAug 2014
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.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Maria E. Cabanillas, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452439
- Sponsor's protocol ID
- ID03-0124
- Other IDs
- NCI-2010-01997
- Status last verified
- Dec 2020
- First submitted
- 23 Mar 2007
- Last updated
- 28 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded Study of Actonel for the Prevention of Bone Loss in Patients Receiving High Dose Corticosteroids for the Treatment of Acute Lymphocytic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
- ClinicalTrials.gov ID
- NCT00452439
- Acronym / sponsor ID
- ID03-0124
- Keywords
- Leukemia, Lymphoma, Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, Actonel, Risedronate, Bone Loss, Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Feb 2004
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Mar 2007 (estimated)
- Results
- Posted 28 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if Actonel (risedronate) can help to prevent the development of osteoporosis (brittle and weak bones) caused by the steroid medication used to treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied.
Detailed description
One of the side effects of using high dose corticosteroids for the treatment of ALL is osteoporosis. Risedronate is a medication that was designed to help prevent osteoporosis (brittle and weak bones).
Before treatment you will receive a complete physical exam. You will have around 1 tablespoon of blood drawn for blood tests (these tests are in addition to the routine blood tests you will have as part of the treatment for leukemia). You will have a urine sample collected for routine tests. You will also have a bone mineral density test. This test measures the density of the bones in your spine, hip, and total body. The test is similar to having x-rays of your bones taken.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in the first group will be given risedronate (once per week), vitamin D (once per day), and calcium (once per day). All three medications are pills and will be taken by mouth. Participants in the second group will be given placebo (once per week), vitamin D (once per day), and calcium (once per day). All three medications are pills and will be taken by mouth. A placebo is a substance that looks like the study drug but has no active ingredients. Neither you nor your doctor will know to which group you are assigned. However, if it is needed for your care, the information will be given to your doctor.
Participants in both groups will continue to receive chemotherapy during this study as scheduled. During chemotherapy, you will have around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests (as part of the standard of care for your treatment of leukemia).
For this study, you will have urine samples collected and repeat bone mineral density tests 6 months, 12 months, 18 months, and 24 months after starting the study drug (or placebo).
If you develop intolerable side effects from the risedronate you will be taken off the study.
This is an investigational study. Risedronate is FDA approved and commercially available. Up to 80 eligible patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actonel | Active comparator | Drug: Actonel (Risedronate), Dietary Supplement: Calcium, Dietary Supplement: Vitamin DActonel (Risedronate) + Vitamin D + Calcium |
| Placebo | Placebo comparator | Dietary Supplement: Calcium, Dietary Supplement: Vitamin DPlacebo + Vitamin D + Calcium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years
- Newly diagnosed ALL or LL receiving chemotherapy with augmented BFM, Hyper-CVAD or any variant of hyper-CVAD.
- Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.
- Negative pregnancy test in female patients.
- Patients must be enrolled within 6 weeks of starting induction chemotherapy.
Key exclusion criteria (8 listed)
- Hypocalcemia of less than 8.4 (corrected to account for the albumin level, [see Appendix E for formula])
- Hypersensitivity to risedronate or other bisphosphonates
- Inability to sit or stand upright for at least 30 minutes
- Bone density T-score of -2.5 S.D or less.
- Renal insufficiency (calculated creatinine clearance <30cc/min,[see Appendix F for formula])
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 |
|---|---|---|
| Actonel (Risedronate)Also: Risedronate Sodium35 mg (pill) by mouth weekly | Drug | Actonel |
| Calcium500 mg by mouth twice a day for a total of 24 months. | Dietary supplement | Actonel, Placebo |
| Vitamin D400 IU by mouth twice a day for a total of 24 months. | Dietary supplement | Actonel, Placebo |
Primary outcome
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months
Time frame: 6 months
bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months.
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months
Time frame: 12 months
bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Maria E. Cabanillas, MD principal investigator
M.D. Anderson Cancer Center
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 Actonel (Risedronate), Calcium and Vitamin D in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center 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 5 inclusion and 8 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 28 Dec 2020. 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. 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 28 Dec 2020). 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?
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. 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 28 Dec 2020.