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J Bone Miner Res. 2019 Aug 16. doi: 10.1002/jbmr.3850. [Epub ahead of print]

Standard vs Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial.

Author information

1
Department of Medicine, Columbia University, New York, NY.
2
Clinical Research Center, Helen Hayes Hospital, West Haverstraw, NY.
3
Department of Pathology and Cell Biology, Columbia University, New York, NY.
4
Department of Epidemiology, Columbia University, New York, NY.

Abstract

In the absence of an intervening antiresorptive agent, cyclic administration of teriparatide does not increase BMD more than standard daily therapy. Since denosumab is a potent antiresorptive agent with a rapid off-effect, we hypothesized that it might be the optimal agent to help maximize bone gains with cyclic teriparatide. In this 3 year protocol, 70 postmenopausal women with osteoporosis were randomized to: 18 months teriparatide followed by 18 months denosumab (Standard) or 3 separate 12 month cycles of 6 months teriparatide followed by 6 months denosumab (Cyclic). BMD (DXA) measurements of lumbar spine (LS), total hip (TH), femoral neck (FN), and 1/3 radius (RAD) were performed every 6 months and Total Body Bone Mineral (TBBM) at 18 and 36 months. Baseline descriptive characteristics did not differ between groups except for a minimal difference in LS BMD, but not T-Score (mean age 65, mean LS T-Score -2.7). In the Standard group, BMD increments at 36 months were: LS 16%, TH 4%, FN 3% and TBBM 4.8% (all p<0.001 vs baseline). In the Cyclic group, 36-month BMD increments were similar: LS 12%, TH 4%, FN 4%, TBBM 4.1% (all p<0.001 vs baseline). At 36 months, the LS BMD increase with Standard was slightly larger than with Cyclic (p=0.04), but at 18 months, in the Cyclic group, there was no decline in RAD or TBBM (p=0.007 and <0.001, respectively vs Standard). Although the Cyclic regimen did not improve BMD compared with Standard at 36 months, there appeared to be a benefit at 18 months, especially in the highly cortical skeletal sites. This could be clinically relevant in patients at high imminent risk of fracture, particularly at nonvertebral sites. This article is protected by copyright. All rights reserved.

KEYWORDS:

Anabolic; Antiresorptive; Denosumab; Sequential; Teriparatide

PMID:
31419313
DOI:
10.1002/jbmr.3850

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