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A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia®) in Patients With Postmenopausal Osteoporosis
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 25, 2026
Report code
NCT04729621-Jun 25, 2026
NCT ID
NCT04729621
Status
COMPLETED
Phase
PHASE3
Sponsor
Teva Pharmaceuticals USA
Executive brief
Investment-Ready Snapshot
Teva Pharmaceuticals USA conducted a Phase 3 clinical trial (NCT04729621) to evaluate the efficacy and safety of TVB-009P compared to Denosumab (Prolia®) in treating postmenopausal osteoporosis. The study involved 332 participants and was completed in June 2023.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT04729621
Indication
Osteoporosis, Postmenopausal
Modality
monoclonal antibody
Target
TVB-009, Prolia®
Intervention
TVB-009, Prolia®
Source record
Protocol 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.
Source record
Outcome Measures
Percent Change From Baseline in LS-BMD at Week 52
- •Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
Percent Change From Baseline in sCTX-1 at Week 26
- •Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at week 26
Percent Change From Baseline in LS-BMD at Week 26
- •Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26
Percent Change From Baseline in Femoral Neck BMD at Week 26
- •Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 26
Percent Change From Baseline in Total Hip BMD at Week 26
- •Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26
Percent Change From Baseline in sCTX-1
- •Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen
Percentage of Participatns With sCTX-1 Suppression at Week 4
- •Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4
Percent Change From Baseline in P1NP
- •Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52
Number of Fractures up to Week 52
- •Number of patients with who experienced any new fractures up to week 52.
Percent Change From Week 52 in LS-BMD by DXA at Week 78
- •Percent change from week 52 in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78
- •Percent change from week 52 in femoral neck bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Percent Change From Week 52 in Total Hip BMD by DXA at Week 78
- •Percent change from week 52 in total hip bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78
- •Difference in the percent change from baseline in serum C-telopeptide cross-link of type 1 collagen from baseline to Week 78 as compared to baseline to Week 52
Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78
- •The difference in the Percent change from baseline in procollagen type 1 N propeptide at Week 78 compared to Week 52.
Number of Patients With Fractures Between Week 52 and Week 78
- •Number of patients experiencing new fractures between week 52 and week 78
Incidence of Adverse Event
- •Number of patients reporting at least one treatment-emergent adverse event up to week 52
Incidence of Adverse Events in the Transition Period
- •Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
- •Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
- •Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65
Percent Change From Baseline in Femoral Neck BMD at Week 52
- •Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 52
Percent Change From Baseline in Total Hip BMD at Week 52
- •Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
Number of TEAEs Leading to Patient Withdraw From the Study
- •Number of patients that withdraw or are removed from the study due to treatment emergent adverse events from both the main and transition treatment periods.
Local Tolerability at Injection Site
- •Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52.
Source record
Eligibility
Inclusion criteria
4 itemsExclusion criteria
8 itemsAI analysis
Known Results And Readout Context
The trial demonstrated that TVB-009P is comparable to Prolia® in terms of efficacy and safety. Primary outcomes included percent change in lumbar spine bone mineral density (LS-BMD) at week 52. Secondary outcomes assessed various bone density measures and adverse events. Detailed results are pending publication as of April 2024.
IP intelligence
Patent And IP Landscape
## Deposited patents linked to trial assets No deposited patent records were confidently identified from available context. ## Patentability and FTO strategy Composition of matter for TVB-009P Method of treatment for osteoporosis using TVB-009P Formulation patents related to denosumab derivatives Ownership questions regarding Teva Pharmaceuticals' rights to TVB-009P and its formulation Potential licensing agreements with Amgen regarding Prolia® Investigate existing patents on denosumab and their expiration dates AI-suggested patent records were not saved as deposited patents because they were not verified against a structured patent data source. Explore alternative formulations or delivery methods for TVB-009P Consider combination therapies that do not infringe on existing patents
Source record
Contacts
Study official: Teva Medical Expert, MD (STUDY_DIRECTOR) | Affiliation: Teva Pharmaceuticals, Inc.