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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Osteoporosis, Postmenopausal

Treatments: Combination Product: TVB-009; Combination Product: Prolia®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04729621

TVB009-IMB-30085

Details and patient eligibility

About

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

Full description

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.

Enrollment: 332 patients

Sex: Female

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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332 participants in 5 patient groups

TVB-009 main treatment period

Experimental group

Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

Treatment:

Combination Product: TVB-009

PROLIA main treatment period

Active Comparator group

Description:

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Treatment:

Combination Product: Prolia®

TVB-009 main / TVB-009 transition period

Experimental group

Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

Treatment:

Combination Product: TVB-009

PROLIA main / PROLIA transition period

Active Comparator group

Description:

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Treatment:

Combination Product: Prolia®

PROLIA main / TVB-009 transition period

Experimental group

Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Treatment:

Combination Product: TVB-009

Combination Product: Prolia®