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

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729621
• Other study ID #: TVB009-IMB-30085
• Status: Completed
• Phase: Phase 3
• Start date: March 22, 2021
• Est. completion date: June 19, 2023

Study information

• Verified date: April 2024
• Source: Teva Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: June 19, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Combination Product:
• TVB-009
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
• Prolia®
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Locations

Country	Name	City	State
Bulgaria	Teva Site 203	Blagoevgrad
Bulgaria	Teva Site 207	Dimitrovgrad
Bulgaria	Teva Site 252	Haskovo
Bulgaria	Teva Site 202	Lom
Bulgaria	Teva Site 205	Plovdiv
Bulgaria	Teva Site 250	Silistra
Bulgaria	Teva Site 201	Sofia
Bulgaria	Teva Site 204	Sofia
Bulgaria	Teva Site 251	Sofia
Bulgaria	Teva Site 206	Stara Zagora
Czechia	Teva Site 211	Brno
Czechia	Teva Site 213	Ostrava
Czechia	Teva Site 212	Pardubice
Czechia	Teva Site 209	Praha
Czechia	Teva Site 210	Praha
Czechia	Teva Site 208	Uherské Hradište
Georgia	Teva Site 214	Tbilisi
Georgia	Teva Site 215	Tbilisi
Georgia	Teva Site 216	Tbilisi
Georgia	Teva Site 217	Tbilisi
Georgia	Teva Site 218	Tbilisi
Georgia	Teva Site 219	Tbilisi
Germany	Teva Site 223	Dresden
Germany	Teva Site 220	Hamburg
Germany	Teva Site 221	Numbrecht
Germany	Teva Site 222	Würzburg
Hungary	Teva Site 226	Balatonfüred
Hungary	Teva Site 225	Budapest
Hungary	Teva Site 227	Budapest
Hungary	Teva Site 253	Budapest
Hungary	Teva Site 224	Nyiregyhaza
Poland	Teva Site 228	Bialystok
Poland	Teva Site 233	Kraków
Poland	Teva Site 231	Lódz
Poland	Teva Site 230	Warsaw
Poland	Teva Site 232	Warsaw
Poland	Teva Site 229	Wroclaw
Russian Federation	Teva Site 235	Moscow
Russian Federation	Teva Site 236	Saint Petersburg
Russian Federation	Teva Site 254	Saint Petersburg
Russian Federation	Teva Site 255	Saint Petersburg
Russian Federation	Teva Site 256	Saint Petersburg
Russian Federation	Teva Site 257	Saint Petersburg
Russian Federation	Teva Site 234	Yaroslavl
Russian Federation	Teva Site 258	Yaroslavl
Slovakia	Teva Site 238	Bratislava
Slovakia	Teva Site 242	Bratislava
Slovakia	Teva Site 237	Hlohovec
Slovakia	Teva Site 240	Lubochna
Slovakia	Teva Site 241	Lucenec
Slovakia	Teva Site 239	Prešov
Ukraine	Teva Site 244	Kyiv
Ukraine	Teva Site 245	Kyiv
Ukraine	Teva Site 247	Kyiv
Ukraine	Teva Site 248	Kyiv
Ukraine	Teva Site 249	Kyiv
Ukraine	Teva Site 243	Vinnytsia
Ukraine	Teva Site 246	Zaporizhia
United States	Teva Site 105	Albuquerque	New Mexico
United States	Teva Site 115	Coral Gables	Florida
United States	Teva Site 108	Duncansville	Pennsylvania
United States	Teva Site 114	Edgewater	Florida
United States	Teva Site 112	Henderson	Nevada
United States	Teva Site 116	Lake City	Florida
United States	Teva Site 109	Miami Lakes	Florida
United States	Teva Site 117	Miami Springs	Florida
United States	Teva Site 107	New London	Connecticut
United States	Teva Site 113	North Las Vegas	Nevada
United States	Teva Site 110	Oldsmar	Florida
United States	Teva Site 120	Orlando	Florida
United States	Teva Site 102	Ormond Beach	Florida
United States	Teva Site 103	Phoenix	Arizona
United States	Teva Site 101	Port Saint Lucie	Florida
United States	Teva Site 118	San Diego	California
United States	Teva Site 111	Sarasota	Florida
United States	Teva Site 106	Seattle	Washington
United States	Teva Site 104	Tamarac	Florida
United States	Teva Site 119	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Teva Pharmaceuticals USA	Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Georgia,  Germany,  Hungary,  Poland,  Russian Federation,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and week 52
Secondary	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	Baseline and week 26
Secondary	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	Baseline and week 26
Secondary	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	Baseline, week 26
Secondary	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	Baseline, week 26
Secondary	Percent Change From Baseline in sCTX-1	Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen	Baseline through Week 52
Secondary	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	Week 4
Secondary	Percent Change From Baseline in P1NP	Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52	Baseline through Week 52
Secondary	Number of Fractures up to Week 52	Number of patients with who experienced any new fractures up to week 52.	Up to week 52
Secondary	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	Week 52 through week 78
Secondary	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	Week 52 through week 78
Secondary	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	Week 52 through week 78
Secondary	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	Baseline, Week 52, Week 78
Secondary	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.	Baseline, Week 52, Week 78
Secondary	Number of Patients With Fractures Between Week 52 and Week 78	Number of patients experiencing new fractures between week 52 and week 78	Week 52 through week 78
Secondary	Incidence of Adverse Event	Number of patients reporting at least one treatment-emergent adverse event up to week 52	Up to week 52
Secondary	Incidence of Adverse Events in the Transition Period	Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78	Week 52 through week 78
Secondary	Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period	Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52	Anytime Post Baseline through Week 52
Secondary	Incidence of Antidrug Antibodies (ADAs) in the Transition Period	Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65	Anytime in Week 52 through Week 78
Secondary	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	Baseline through Week 52
Secondary	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	Baseline through Week 52
Secondary	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.	Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78
Secondary	Local Tolerability at Injection Site	Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52.	Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52