Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss

Phase 3 Completed 135 enrolled M.D. Anderson Cancer Center Novartis · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: * Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck. Secondary Objectives: * Evaluate the effect of zoledronate on change in BMD at the total hip * Evaluate risk factors for developing osteoporosis on chemotherapy * Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).

Timeline

Start: 2006-01
Primary completion: 2011-09
Completion: 2011-09

Outcome

Met primary endpoint

paper 24 received ZA and had stable BMD during the observation period, whereas 29 patients in the control group had decreased BMD (P < .05 PMID 23276888 ↗

Publications

Westin JR, Thompson MA, Cataldo VD, Fayad LE, Fowler N, Fanale MA, Neelapu S, Samaniego F, Romaguera J, Shah J, McLaughlin P, Pro B, Kwak LW, Sanjorjo P, Murphy WA, Jimenez C, Toth B, Dong W, Hagemeister FB. Zoledronic acid for prevention of bone loss in patients receiving primary therapy for lymphomas: a prospective, randomized controlled phase III trial. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):99-105. doi: 10.1016/j.clml.2012.11.002. Epub 2012 Dec 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zoledronic acid	Other / unclassified	4 mg/m2	Intravenous
Background	Calcium carbonate	Other / unclassified	1200 mg	Oral
Background	Vitamin D	Other / unclassified	400 mg	Oral