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Teriparatide patch deemed safe, effective to increase postmenopausal BMD
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The delivery of teriparatide via novel transdermal patch appears to be a safe and efficacious alternative to injection for increasing lumbar spine and total hip bone mineral density in postmenopausal women with osteoporosis.
A recent study, performed at 13 centers in the Unites States, Mexico and Argentina, compared the use of self-administered transdermal teriparatide patches (20 mcg, 30 mcg and 40 mcg) with a placebo patch and subcutaneous teriparatide injection (20 mcg; Forteo, Eli Lilly). Patch interventions were worn for 30 minutes pr day. The randomized, placebo-controlled study included 165 postmenopausal women (mean age, 64 years) with osteoporosis.
Lumbar spine BMD increased in both the teriparatide patch and injection treatment groups from baseline to three months, and continued to rise from three to six months. At six months, the mean percentage change in the teriparatide patch group from baseline was 2.96% with the 20-mcg dose, 3.47% with the 30-mcg dose and 4.97% with the 40-mcg dose. The group assigned to the 20-mcg injection experienced a 3.55% increase. The placebo patch group had a decrease in lumbar spine BMD of –0.33% (P<.001).
Total hip BMD also increased in both the teriparatide patch (40 mcg, 1.33%) and injection (0.09%) treatment groups at six months, and decreased in the placebo patch group (–0.63%).
Bone turnover markers, including procollagen type 1 N-terminal propeptide and C-terminal cross-linked telopeptide of type 1 collagen, increased in a dose-dependent fashion from baseline in all treatment groups and were significantly different from the placebo patch (P<.001).
Teriparatide patch doses were well tolerated. Adverse event were not different between the teriparatide patch and injection groups. All women had transient mild to moderate erythema at the patch site. There were few incidents of edema, punctate bruising or pinpoint bleeding at the administration site. The researchers reported no episodes of delayed hypersensitivity, skin infection or human antibodies to teriparatide.
“The transdermal teriparatide microneedle patch is an effective delivery system,” the researchers concluded. “Over six months, the 40 mcg dose provided a significant lumbar spine bone BMD and total hip BMD change that was similar to the teriparatide injection treatment currently approved for the treatment of osteoporosis.”
Additional studies are planned to explore the safety and efficacy of the novel teriparatide patch for a period longer than six months, they noted.
Cosman C. J Clin Endocrinol Metab. 2009; 95:151-158.