CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 72 enrolled
Drug / intervention
Actonel (Risedronate) +2 moredrug
Likely dose
Actonel (Risedronate) 35 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00452439
NCT00452439Phase 3Completed
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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)

M.D. Anderson Cancer Center·interventional·Posted Mar 27, 2007·Updated Dec 28, 2020

In Brief

A Phase 3 clinical trial evaluating Actonel (Risedronate), Calcium, and 1 other intervention for Leukemia and Lymphoma. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma
CountriesUnited States
CollaboratorsProcter and Gamble

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2007
Enrollment StartFeb 1, 2004
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 19.3 years ago

Interventions

Actonel (Risedronate)drug

35 mg (pill) by mouth weekly

Calciumdietary

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

Vitamin Ddietary

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