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DATA extension study: two years of Denosumab and Teriparatide in postmenopausal women with osteoporosis

Current osteoporosis medications increase bone mineral density ( BMD ) modestly and reduce, but do not eliminate, fracture risk. Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful.
Conversely, 12-months of concomitant Denosumab ( Prolia ) and Teriparatide ( Forsteo, Forteo ) therapy increases bone mineral density more than either drug alone.

A study has determined if 24-months of combined Denosumab and Teriparatide will increase hip and spine bone mineral density more than either individual agent.
In the pre-planned continuation of the DATA ( Denosumab and Teriparatide Administration ) trial, 94 postmenopausal osteoporotic women received Teriparatide (20-mcg daily ), Denosumab ( 60-mg every 6-months ), or both medications for 24-months.

At 24 months, lumbar spine bone mineral density increased more in the combination group ( 12.9±5.0% ) than both the Teriparatide ( 9.5±5.9%, P=0.01 ) and Denosumab ( 8.3±3.4%, P=0.008 ) groups.
Femoral neck bone mineral density also increased more in the combination group ( 6.8±3.6% ) than both the Teriparatide ( 2.8±3.9%, P=0.003 ) and Denosumab ( 4.1±3.8%, P=0.008 ).

Similarly, total hip bone mineral density increased more in the combination group ( 6.3±2.6% ) than in the Teriparatide ( 2.0±3.0% ) or Denosumab ( 3.2±2.5% ) groups ( P less than 0.001 for both ).

While spine and hip bone mineral density continued to increase in the second year in all groups, these year-2 increases did not differ between groups.

Serum C-terminal telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the Denosumab and combination groups whereas osteocalcin decreased more in the Denosumab group than the combination group, a difference that persisted, but lessened, in the second year of therapy.

In conclusion, two years of concomitant Teriparatide and Denosumab therapy increases bone mineral density more than either medication alone and more than has been reported with any current therapy.
The combination of these agents may prove to be an important treatment option in patients at high risk of fracture. ( Xagena )

Leder BZ et al, J Clin Endocrinol Metab 2014; Epub ahead of print

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