Osteoporosis: high-dose teriparatide combo rapidly increases BMD

  • Lancet Diabetes Endocrinol.

  • von Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • High-dose (40 μg) vs standard dose (20 μg) teriparatide (Forteo) with denosumab (Xgeva, Prolia) 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.

Study design

  • DATA-HD (n=69) was a randomized controlled trial at Massachusetts General Hospital 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.

Key results

  • 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>
  • The high-dose (vs standard dose) group had similar total adverse events (AEs: 78% and 77%), but fewer serious AEs (5% vs 18%).
  • Most frequent AEs with high-dose teriparatide were fatigue (38%), nausea (43%), and joint pain (46%).
    • Joint pain (38%), muscle cramp (38%), and fatigue (31%) were most common with standard dosing.

Limitations

  • Open-label, single-center study.