American society for bone and mineral research.

Combination therapy with daily teriparatide (Forteo, Eli Lilly) and a once-yearly 5-mg zoledronic acid injection (Reclast, Novartis) provided the most rapid increases in BMD at both spine and hip and may be considered for patients at a high risk of fracture, according to new study results. Bisphosphonates suppress bone remodeling, and para thyroid hormone (PTH) and teriparatide stimulate bone formation. While the combination is theoretically promising, experience has suggested that daily bisphosphonates may blunt PTH-induced bone formation. Dr. Cosman’s study tested whether a one-time infusion of zoledronic acid, combined with daily teriparatide, could overcome this effect. The primary objective was to determine whether this combination’s effect on lumbar spine BMD was non-inferior to teriparatide alone. The trial included 412 treatment-naive women (mean age, 65 years) at 35 centers in four countries. All had T-scores of –2.5 or lower at the femoral neck, hip, or spine or T-scores of –2 or lower at any site, plus one or more documented osteoporosis-related fractures. Patients were randomly assigned to receive intravenous (IV) zoledronic acid 5 mg at baseline with or without subcutaneous (SQ) teriparatide 20 mcg/day or IV placebo at baseline plus teriparatide at a dose of 20 mcg/day. All women received 1,000 to 1,200 mg of calcium and 400 to 800 IU of vitamin D daily. At one year, the combination produced increases in lumbar spine BMD that were similar to those of teriparatide alone and greater increases than with zoledronic acid alone (P = 0.0001). At one year, hip BMD increased with the combination, similar to that seen with zoledronic acid alone and greater than that with teriparatide alone (P < 0.05). Clinical fractures were reported in 2.9% of patients receiving the combination, in 5.8% American Society for Bone and Mineral Research