Two Years of Denosumab and Teriparatide Administration in Postmenopausal Women With Osteoporosis (The DATA Extension Study): A Randomized Controlled Trial

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94 postmenopausal women, >45 years of age, who had been diagnosed with osteoporosis and who were at high risk for fracture, were randomly assigned into 1 of 3 treatment groups to determine the long term effect (24 months) a combination of denosumab and teriparatide had on hip and spine BMD. Patients either received a combined drug treatment of denosumab and teriparatide, or intervention with denosumab or teriparatide alone. At 24 months, lumbar spine, femoral neck, and total hip BMD was significantly higher in the combination group when compared to the single dose groups. Spine and hip BMD continued to increase in the second year in all groups, but no difference in the rate at which BMD increased was noted during the second year follow up (12 to 24 months). Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were suppressed in similar amounts in the denosumab and combination groups. Serum osteocalcin decreased by a significantly greater amount in the denosumab group than in the combination group.