Osteoporosis medications increase bone-mineral density ( BMD ) and lower but do not eliminate fracture risk. The combining of anabolic agents with bisphosphonates has not improved efficacy.
Researchers have compared combined Teriparatide ( Forsteo, Forteo ) and Denosumab ( Prolia ) with both agents alone.
From September, 2009, to January, 2011, investigators have enrolled postmenopausal women with osteoporosis into this randomised, controlled trial.
Patients were assigned in a 1:1:1 ratio to receive 20 mcg Teriparatide daily, 60 mg Denosumab every 6 months, or both.
Bone-mineral density was measured at 0, 3, 6, and 12 months. Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat analysis.
94 ( 94% ) of 100 eligible women completed at least one study visit after baseline. At 12 months, posterior-anterior lumbar spine bone-mineral density increased more in the combination group ( 9.1%, than in the Teriparatide ( 6.2%, p=0.0139 ) or Denosumab ( 5.5%, p=0.0005 ) groups.
Femoral-neck bone-mineral density also increased more in the combination group ( 4.2% ) than in the Teriparatide ( 0.8%, p=0.0007 ) and Denosumab ( 2.1%, p=0.0238 ) groups, as did total-hip bone-mineral density ( combination, 4.9%; Teriparatide, 0.7%, p less than 0.0001; Denosumab 2.5%, p=0.0011 ).
The study has shown that combined Teriparatide and Denosumab increased bone-mineral density more than either agent alone and more than has been reported with approved therapies.
Combination treatment might, therefore, be useful to treat patients at high risk of fracture. ( Xagena )
Tsai JN et al, The Lancet 2013; 382: 50-56