Novel combination therapy improves bone mineral density in postmenopausal osteoporosis

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1. The combination of teriparatide and enosumab increased bone mineral density in postmenopausal women with osteoporosis more than either agent alone. 

2. The combination of PTH and a RANKL inhibitor may be a useful option for the prevention of osteoporosis, especially in women at high risk of fracture. 

Evidence Rating Level: 1 (Excellent) 

Study Rundown: Researchers found that a combination of teriparatide, a recombinant PTH, and denosumab, a RANKL inhibitor, increased bone mineral density in postmenopausal women with osteoporosis more than either drug treatment alone. The novel findings of this trial suggest that combination therapy may be an effective treatment for women at high risk of fracture. This is the first study to examine this therapeutic combination in humans, verifying previously studies that found a combination benefit in animal models. While the demonstrated increase in BMD is impressive, the study was not powered to find a difference in fracture rates, the more significant clinical outcome. Moreover, it is a relatively small study with a fairly homogenous study sample. While the results are promising, further larger scale trials focused on fracture risk, safety, and long-term effects/benefits are needed before any concrete clinical recommendations can be made.

Click to read the study in The Lancet

Click to read an accompanying editorial in The Lancet

Click to read about this trial on ClinicalTrials.gov

In-Depth [prospective randomized controlled trial]: From September 2009-Januarry 2011, researchers recruited 100 postmenopausal women (>36 months since last menses) with osteoporosis. Women were randomized to receive either 60 mg denosumab (Prolia/Xgeva; a monoclonal antibody RANKL inhibitor that inhibits osteoclasts and thus bone turnover) every 6 months, 20 ug teriparatide (Forteo; recombinant Parathyroid Hormone) every day, or both for 12 months. Follow-up bone mineral density (BMD) assessment by DEXA scan was conducted at 3,6, and 12-month intervals.

Of the 100 women enrolled, 94 (94%) completed at least 1 baseline study visit and were included in the analysis. At the 1 year follow-up, the combination group had an increase in posterior-anterior lumbar spine BMD of 9.1%, significantly more than with either the teriparatide (6.2%, p=0.0139) or denosumab (5.5%, p=0.0005) alone. The combination group also had an increase in femoral-neck and total-hip BMD that was significantly higher than either medication alone.

By Maren Shapiro and Leah Hawkins

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