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

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Teva Pharmaceuticals USA
Updated on 10 April 2021


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.

Condition Postmenopausal osteoporosis, Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
Treatment Prolia®, TVB-009
Clinical Study IdentifierNCT04729621
SponsorTeva Pharmaceuticals USA
Last Modified on10 April 2021


Yes No Not Sure

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
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