[Therapeutic agents for disorders of bone and calcium metabolism. Development of nasal formulation of hPTH (1-34)].
Intermittent administration of parathyroid hormone (PTH) has been shown to have strong anabolic effects on bone. However, the disadvantages associated with daily subcutaneous injection therapy are factors influencing patient acceptance and compliance. We have developed a nasal spray formula of hPTH (1-34), and found that peak serum hPTH (1-34) concentrations after treatment with nasal hPTH (1-34) spray are similar to those obtained after administration sc injection of hPTH (1-34). In order to determine clinical efficacy as well as safety and tolerability of nasal hPTH (1-34) spray therapy, a clinical trial was conducted in subjects with osteoporosis. Daily nasal hPTH (1-34) spray for 3 months significantly increased lumbar bone mineral density (L-BMD) in a dose-dependent manner. In addition, it was observed that one part of the L-BMD increases was a result of stimulating bone formation by the bone formation marker monitoring. Interestingly, bone resorption markers did not increase but were suppressed after 3 months, suggesting that there may be a different mechanism involved when comparing nasal hPTH (1-34) therapy with hPTH (1-34) sc administration.
Sato
Katsuhiko
K
Chugai Clinical Research Center Co., Ltd.
D000281:Administration, Intranasal; D015519:Bone Density / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D015195:Drug Design; D006801:Humans; D010012:Osteogenesis / Q000187:drug effects; D010024:Osteoporosis / Q000188:drug therapy* / Q000503:physiopathology; D019379:Teriparatide / Q000008:administration & dosage* / Q000097:blood / Q000494:pharmacology; D013997:Time Factors
D019379:Teriparatide