NCT00452439

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at below P25 for phase_3 leukemia

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_3 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

December 28, 2020

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

10.5 years

First QC Date

March 23, 2007

Results QC Date

November 9, 2020

Last Update Submit

December 2, 2020

Conditions

LeukemiaLymphoma

Keywords

LeukemiaLymphomaAcute Lymphocytic LeukemiaLymphoblastic LymphomaActonelRisedronateBone LossOsteoporosis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    12 months

Study Arms (2)

Actonel

ACTIVE COMPARATOR

Actonel (Risedronate) + Vitamin D + Calcium

Drug: Actonel (Risedronate)Dietary Supplement: CalciumDietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo + Vitamin D + Calcium

Dietary Supplement: CalciumDietary Supplement: Vitamin D

Interventions

Actonel (Risedronate)DRUG

35 mg (pill) by mouth weekly

Also known as: Risedronate Sodium
Actonel
CalciumDIETARY_SUPPLEMENT

500 mg by mouth twice a day for a total of 24 months.

ActonelPlacebo
Vitamin DDIETARY_SUPPLEMENT

400 IU by mouth twice a day for a total of 24 months.

ActonelPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaBone Diseases, MetabolicOsteoporosis

Interventions

Risedronic AcidCalciumVitamin D

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Maria Cabanillas, Associate Professor, Endocrine Neoplasia and HD
Organization
University of Texas (UT) MD Anderson Cancer Center
mcabani@mdanderson.org
(713) 563-0764

Study Officials

  • Maria E. Cabanillas, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 27, 2007

Study Start

February 1, 2004

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 28, 2020

Results First Posted

December 28, 2020

Record last verified: 2020-12

Locations

US(1)