OP Epidemiology
According to the data from the Health Commission (2018), the number of osteopenia and OP patients in China has reached more than 300 million, and the prevalence of OP among people over 50 years old is 19.2%. The prevalence of OP among people over 65 years old reached 32.0%, among which 51.6% were women.
• Diet: Take adequate calcium and vitamins, and adopt a gluten free diet to improve bone density.
• Physical exercise
• Medication
Abbapatide: subcutaneous injection changes the route of percutaneous penetration
Osteoporosis treatment requires long-term medication. The initial dosage form of abalone peptide is subcutaneous injection, but it is not easy to develop into oral dosage form as a polypeptide drug. Therefore, in order to improve drug compliance, Radius Health, the original research company, developed microneedle transdermal drug delivery. According to the registration requirements of 505b (2), the development path adopts the development strategy of large clinic, and the clinical scheme uses subcutaneous injection as the control. At present, it is in Ph3 stage.Randomized single blind open label non inferiority bridge clinical trial design scheme | ||||
Phase | Enrollment | Interventional | Primary Endpoint | Results |
3 | 474 | Abaloparatide-SC | BMD (Time Frame:12 months)(percent change from baseline in BMD ) |
Abalo-TD 7.1% (95% CI: 6.2, 8.0) vs. baseline Abalo-SC 10.9% (95% CI: 9.9, 11.8) vs. baseline Difference:-3.7% (95% CI: -5.0, -2.4) |
Abaloparatide-TD | ||||
2 | 250 | Abaloparatide-SC | BMD (Time Frame:6 months)(percent change from baseline in BMD ) | NA |
Abaloparatide-TD | ||||
Placebo | ||||
Note: BMD: bone mineral density Abaloparatide-SC:Abbapatide - subcutaneous injection; Abaloparatide TD: Abalapatide transdermal |
Lindmik Pharmaceutical(Suzhou)Co.,Ltd is a high-tech pharmaceutical enterprise focusing on the research and development, production and sales of innovative pharmaceutical preparations.Equipped with a number of its own innovative R&D platform of dosage forms, including the transdermal drug delivery system, and at the same time, actively introducing the world’s leading nano-based drug delivery, microspheres drug delivery and other cutting-edge pharmaceutical technologies by means of “license in”, the company is a new rapidly developing company pharmaceutical companies that catches people’s eyes.
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