A Phase 3 interventional study of ibandronate [Bondronat] and zoledronic acid in Pain, Bone Neoplasm and Neoplasm Metastasis, sponsored by Hoffmann-La Roche. Terminated at 41 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-16.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 96 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
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Exclusion Criteria:
Drug: ibandronate [Bondronat]
Drug: zoledronic acid
6mg iv on days 1-3, and 50mg po from day 22 to week 24
4mg iv on day 1, and every 3-4 weeks
Pain, as measured by Brief Pain Inventory and analgesic use
Time frame: Week 24
Performance score and QoL measures
Time frame: Week 24
AEs and laboratory parameters
Time frame: Throughout study
Opioid side effects
Time frame: Throughout study
Skeletal-related events
Time frame: Throughout study
This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ibandronic Acid