- High-dose (40 μg) vs standard dose (20 μg) teriparatide with denosumab delivered large and rapid BMD increases in a phase 4 trial of postmenopausal patients with osteoporosis.
Why this matters
- Increases were larger than observed with other drugs, alone or in combination, suggesting that the therapeutic regimen provides a way to "restore skeletal integrity" in osteoporosis, according to authors.
- DATA-HD (n=69) was a randomised controlled trial comparing high-dose or standard dose teriparatide subcutaneously (SC) daily for 9 months; at 3 months, both groups started 60 mg denosumab every 6 months SC for 12 months.
- Funding: NIH; Dart Foundation.
- At 15 months, the high-dose vs standard dose group had greater:
- Mean spine areal BMD (aBMD): 17.5% vs 9.5% increase from baseline (difference, 8.1%; P<.0001>
- Mean femoral neck aBMD: 6.8% vs 4.3% (difference, 2.5%; P=.04).
- Mean total hip aBMD: 6.1% vs 3.9% (difference, 2.2%; P<.0001>
- Joint pain (38%), muscle cramp (38%), and fatigue (31%) were most common with standard dosing.
- Open-label, single-centre study.