A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis

A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia®) in Patients With Postmenopausal Osteoporosis

The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)

This is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60 mg every 26 weeks. Approximately 326 postmenopausal women with osteoporosis will be randomized to receive either TVB-009 or Prolia®. At week 52, patients in the Prolia® arm will be re-randomized 1:1 to either continue with a third dose of Prolia® or transition to TVB-009 and receive a single dose of TVB-009 in the transition period to assess immunogenicity and safety after a transition from Prolia® to TVB-009. The total treatment duration for each patient is 78 weeks.

Inclusion Criteria:

• Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis
• Body weight ≥50 kg and ≤90 kg
• Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening
• At least 3 vertebrae in the L1 L4 region that are evaluable by dual-energy X-ray absorptiometry (DXA)

Exclusion Criteria:

• One severe or more than two moderate vertebral fractures
• History and/or presence of hip fracture or atypical femur fracture
• Any prior treatment with denosumab
• Ongoing use of any bone active drugs which can affect Bone Mineral Density (BMD)
• Vitamin D deficiency or hyper- or hypocalcemiacium at screening
• Hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism
• Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study

Other Inclusion/exclusion criteria may apply