This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Berenson, J. R. Articles by Swift, R. A. PubMed PubMed Citation Articles by Berenson, J. R. Articles by Swift, R. A.

Zoledronic Acid Markedly Improves Bone Mineral Density for Patients with Monoclonal Gammopathy of Undetermined Significance and Bone Loss

Authors' Affiliations: ¹ Oncotherapeutics, ² Institute for Myeloma and Bone Cancer Research, and ³ James R. Berenson, M.D., Inc., Los Angeles, California; ⁴ Center for Cancer and Blood Disorders, Bethesda, Maryland; ⁵ Hematology-Oncology Medical Group, Fresno, California; ⁶ Hematology-Oncology Medical Group of Orange County, Orange, California; ⁷ SUNY Downstate Medical Center, Brooklyn, New York; ⁸ Florida Oncology Associates, Jacksonville, Florida; and ⁹ Florida Cancer Specialists, Bonita Springs, Florida

Requests for reprints: James R. Berenson, Oncotherapeutics, 9201 West Sunset Boulevard, Suite 317, West Hollywood, CA 90069. Phone: 310-623-1200; Fax: 310-623-1121; E-mail: jberenson{at}imbcr.org.

Purpose: Patients with monoclonal gammopathy of undetermined significance (MGUS) have increased rates of bone resorption, osteopenia, osteoporosis, and risk of fractures. This study was undertaken to determine the efficacy and safety of zoledronic acid for patients with MGUS and enhanced bone loss.

Experimental Design: In this phase II open-label study, 54 patients with MGUS and osteopenia or osteoporosis were administered zoledronic acid 4 mg i.v. at 0, 6, and 12 months. The primary efficacy end point was bone mineral density, assessed using a dual-energy X-ray absorptiometry scan in the lumbar (L)-spine done at screening and at 13 months (1 month after the final zoledronic acid infusion).

Results: At study end for all patients (N = 54), L-spine T-scores improved by a median of +0.27 (range, –0.38 to +3.91), corresponding to a median increase in bone mineral density of +15.0% (range, –18.0% to +1,140.0%; P < 0.0001). Hip T-scores improved by a median of +0.10 (range, –2.40 to +2.03), corresponding to a median increase of +6.0% (range, –350.0% to +165.0%). During the study, no new fractures, osteonecrosis of the jaw, or significant renal adverse events were reported.

Conclusions: Zoledronic acid administered i.v. at a dosage of 4 mg every 6 months for three doses total was well-tolerated and substantially improved bone mineral density for patients with MGUS and bone loss. Zoledronic acid may be effective for the prevention of new fractures in this high-risk population.