Managing bone health with zoledronic acid: a review of randomized clinical study results

Abstract

Aim To systematically review randomized, controlled clinical trials for managing osteoporosis, cancer treatment-induced bone loss, and bone metastases from breast cancer using zoledronic acid (ZOL).

Methods A systematic review of published literature and meeting abstracts was conducted to examine the efficacy of ZOL dosing strategies in clinical trials of osteoporosis, adjuvant therapy for breast cancer, and bone metastases from breast cancer. Bone resorption rates, tumor burden, skeletal health goals, and clinical data were considered when assessing ZOL in each setting.

Results Dosing schedules vary between approved indications for osteoporosis and bone metastases and the investigational use in women receiving endocrine therapy for BC, taking into consideration the different levels of bone loss and tumor burden in each setting. Gradual bone loss in healthy postmenopausal women with osteopenia or osteoporosis can be prevented or treated with the approved biennial or annual ZOL (5 mg), respectively. Rapid bone loss in patients receiving adjuvant chemotherapy and/or endocrine therapy for early-stage BC and low tumor burden is managed in the clinical setting with ZOL 4 mg every 6 months. In patients with bone metastases, very high tumor burden, high bone resorption levels, and decreases in bone integrity are managed by the approved ZOL schedule (4 mg every 3–4 weeks) to prevent skeleton-related events.

Conclusions Dosing schedules are based on clinical evidence and vary depending on goals of therapy, rate of bone loss, and tumor burden. ZOL 5 mg every 12 months and every 24 months are approved for osteoporosis and osteopenia, respectively, whereas ZOL 4 mg every 6 months has been used during adjuvant endocrine therapy and ZOL 4 mg every 3–4 weeks is approved for managing bone metastases.

Key words:

• ANTICANCER
• AROMATASE INHIBITOR
• BISPHOSPHONATE
• BREAST CANCER
• FRACTURE
• OSTEOPOROSIS

Acknowledgements

Novartis Medical has reviewed this manuscript for scientific accuracy. I thank Michael Hobert, PhD, ProEd Communications, Inc.®, for his medical editorial assistance with this manuscript.

Conflict of interest Dr Hadji has received honoraria, unrestricted educational grants, and research funding from the following companies: Amgen, AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, Roche, sanofi-aventis, and Wyeth.

Source of funding Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation.