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

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TVB-009
Prolia®
Sponsored by
Teva Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Teva Site 103
  • Teva Site 119
  • Teva Site 118
  • Teva Site 107
  • Teva Site 115
  • Teva Site 114
  • Teva Site 116
  • Teva Site 109
  • Teva Site 117
  • Teva Site 110
  • Teva Site 120
  • Teva Site 102
  • Teva Site 101
  • Teva Site 111
  • Teva Site 104
  • Teva Site 112
  • Teva Site 113
  • Teva Site 105
  • Teva Site 108
  • Teva Site 106
  • Teva Site 203
  • Teva Site 207
  • Teva Site 252
  • Teva Site 202
  • Teva Site 205
  • Teva Site 250
  • Teva Site 201
  • Teva Site 204
  • Teva Site 251
  • Teva Site 206
  • Teva Site 211
  • Teva Site 213
  • Teva Site 212
  • Teva Site 209
  • Teva Site 210
  • Teva Site 208
  • Teva Site 214
  • Teva Site 215
  • Teva Site 216
  • Teva Site 217
  • Teva Site 218
  • Teva Site 219
  • Teva Site 223
  • Teva Site 220
  • Teva Site 221
  • Teva Site 222
  • Teva Site 226
  • Teva Site 225
  • Teva Site 227
  • Teva Site 253
  • Teva Site 224
  • Teva Site 228
  • Teva Site 233
  • Teva Site 230
  • Teva Site 232
  • Teva Site 229
  • Teva Site 231
  • Teva Site 235
  • Teva Site 236
  • Teva Site 254
  • Teva Site 255
  • Teva Site 256
  • Teva Site 257
  • Teva Site 234
  • Teva Site 258
  • Teva Site 238
  • Teva Site 242
  • Teva Site 237
  • Teva Site 240
  • Teva Site 241
  • Teva Site 239
  • Teva Site 244
  • Teva Site 245
  • Teva Site 247
  • Teva Site 248
  • Teva Site 249
  • Teva Site 243
  • Teva Site 246

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

TVB-009 main treatment period

PROLIA main treatment period

TVB-009 main / TVB-009 transition period

PROLIA main / PROLIA transition period

PROLIA main / TVB-009 transition period

Arm Description

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

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

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

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

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

Outcomes

Primary 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

Secondary Outcome Measures

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
Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 26 and at week 52
Percent change from baseline in total hip BMD
Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26 and at week 52
Percent change from baseline in sCTX-1
Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen
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) at week 26 and week 52
Incidence of fractures up to week 52
Number of patients with 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 at weeks 52 and 78
Difference between percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at weeks 52 and 78
Difference between percent change from baseline in P1NP at weeks 52 and 78
Difference between percent change from baseline in procollagen type 1 N propeptide at weeks 52 and 78
Incidence of fractures between week 52 and week 78
Number of patients with fractures between week 52 and week 78
Incidence of adverse event and withdrawals due to adverse events
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 up to week 52
Incidence of antidrug antibodies (ADAs) in the transition period
Number of patients with confirmed positive antidrug antibodies (ADAs) between week 52 and 78

Full Information

First Posted
January 25, 2021
Last Updated
June 21, 2023
Sponsor
Teva Pharmaceuticals USA
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04729621
Brief Title
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
June 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Pharmaceuticals USA
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TVB-009 main treatment period
Arm Type
Experimental
Arm Description
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
Arm Title
PROLIA main treatment period
Arm Type
Active Comparator
Arm Description
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Arm Title
TVB-009 main / TVB-009 transition period
Arm Type
Experimental
Arm Description
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period
Arm Title
PROLIA main / PROLIA transition period
Arm Type
Active Comparator
Arm Description
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Arm Title
PROLIA main / TVB-009 transition period
Arm Type
Experimental
Arm Description
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Intervention Type
Combination Product
Intervention Name(s)
TVB-009
Intervention Description
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Intervention Type
Combination Product
Intervention Name(s)
Prolia®
Intervention Description
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Primary Outcome Measure Information:
Title
Percent change from baseline in LS-BMD at week 52
Description
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
Time Frame
Baseline and week 52
Secondary Outcome Measure Information:
Title
Percent change from baseline in sCTX-1 at week 26
Description
Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at week 26
Time Frame
Baseline and week 26
Title
Percent change from baseline in LS-BMD at week 26
Description
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
Time Frame
Baseline and week 26
Title
Percent change from baseline in femoral neck BMD
Description
Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 26 and at week 52
Time Frame
Baseline, week 26, week 52
Title
Percent change from baseline in total hip BMD
Description
Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26 and at week 52
Time Frame
Baseline, week 26, week 52
Title
Percent change from baseline in sCTX-1
Description
Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen
Time Frame
Baseline through week 52
Title
sCTX-1 suppression at week 4
Description
Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4
Time Frame
Week 4
Title
Percent change from baseline in P1NP
Description
Percent change from baseline in procollagen type 1 N propeptide (P1NP) at week 26 and week 52
Time Frame
Baseline, week 26, week 52
Title
Incidence of fractures up to week 52
Description
Number of patients with fractures up to week 52
Time Frame
Up to week 52
Title
Percent change from week 52 in LS-BMD by DXA at week 78
Description
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
Time Frame
Week 52 through week 78
Title
Percent change from week 52 in femoral neck BMD by DXA at week 78
Description
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
Time Frame
Week 52 through week 78
Title
Percent change from week 52 in total hip BMD by DXA at week 78
Description
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
Time Frame
Week 52 through week 78
Title
Difference between percent change from baseline in sCTX-1 at weeks 52 and 78
Description
Difference between percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at weeks 52 and 78
Time Frame
Week 52 through week 78
Title
Difference between percent change from baseline in P1NP at weeks 52 and 78
Description
Difference between percent change from baseline in procollagen type 1 N propeptide at weeks 52 and 78
Time Frame
Week 52 through week 78
Title
Incidence of fractures between week 52 and week 78
Description
Number of patients with fractures between week 52 and week 78
Time Frame
Week 52 through week 78
Title
Incidence of adverse event and withdrawals due to adverse events
Description
Number of patients reporting at least one treatment-emergent adverse event up to week 52
Time Frame
Up to week 52
Title
Incidence of adverse events in the transition period
Description
Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78
Time Frame
Week 52 through week 78
Title
Incidence of antidrug antibodies (ADAs) in the main treatment period
Description
Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline up to week 52
Time Frame
Up to week 52
Title
Incidence of antidrug antibodies (ADAs) in the transition period
Description
Number of patients with confirmed positive antidrug antibodies (ADAs) between week 52 and 78
Time Frame
Week 52 through week 78

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Site 103
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Teva Site 119
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Teva Site 118
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Teva Site 107
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Teva Site 115
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Teva Site 114
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Teva Site 116
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Teva Site 109
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Teva Site 117
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Teva Site 110
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Teva Site 120
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Teva Site 102
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Teva Site 101
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Teva Site 111
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Teva Site 104
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Teva Site 112
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Teva Site 113
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Teva Site 105
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Teva Site 108
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Teva Site 106
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Teva Site 203
City
Blagoevgrad
Country
Bulgaria
Facility Name
Teva Site 207
City
Dimitrovgrad
Country
Bulgaria
Facility Name
Teva Site 252
City
Haskovo
Country
Bulgaria
Facility Name
Teva Site 202
City
Lom
Country
Bulgaria
Facility Name
Teva Site 205
City
Plovdiv
Country
Bulgaria
Facility Name
Teva Site 250
City
Silistra
Country
Bulgaria
Facility Name
Teva Site 201
City
Sofia
Country
Bulgaria
Facility Name
Teva Site 204
City
Sofia
Country
Bulgaria
Facility Name
Teva Site 251
City
Sofia
Country
Bulgaria
Facility Name
Teva Site 206
City
Stara Zagora
Country
Bulgaria
Facility Name
Teva Site 211
City
Brno
Country
Czechia
Facility Name
Teva Site 213
City
Ostrava
Country
Czechia
Facility Name
Teva Site 212
City
Pardubice
Country
Czechia
Facility Name
Teva Site 209
City
Praha
Country
Czechia
Facility Name
Teva Site 210
City
Praha
Country
Czechia
Facility Name
Teva Site 208
City
Uherské Hradiště
Country
Czechia
Facility Name
Teva Site 214
City
Tbilisi
Country
Georgia
Facility Name
Teva Site 215
City
Tbilisi
Country
Georgia
Facility Name
Teva Site 216
City
Tbilisi
Country
Georgia
Facility Name
Teva Site 217
City
Tbilisi
Country
Georgia
Facility Name
Teva Site 218
City
Tbilisi
Country
Georgia
Facility Name
Teva Site 219
City
Tbilisi
Country
Georgia
Facility Name
Teva Site 223
City
Dresden
Country
Germany
Facility Name
Teva Site 220
City
Hamburg
Country
Germany
Facility Name
Teva Site 221
City
Numbrecht
Country
Germany
Facility Name
Teva Site 222
City
Würzburg
Country
Germany
Facility Name
Teva Site 226
City
Balatonfüred
Country
Hungary
Facility Name
Teva Site 225
City
Budapest
Country
Hungary
Facility Name
Teva Site 227
City
Budapest
Country
Hungary
Facility Name
Teva Site 253
City
Budapest
Country
Hungary
Facility Name
Teva Site 224
City
Nyiregyhaza
Country
Hungary
Facility Name
Teva Site 228
City
Białystok
Country
Poland
Facility Name
Teva Site 233
City
Kraków
Country
Poland
Facility Name
Teva Site 230
City
Warsaw
Country
Poland
Facility Name
Teva Site 232
City
Warsaw
Country
Poland
Facility Name
Teva Site 229
City
Wrocław
Country
Poland
Facility Name
Teva Site 231
City
Łódź
Country
Poland
Facility Name
Teva Site 235
City
Moscow
Country
Russian Federation
Facility Name
Teva Site 236
City
Saint Petersburg
Country
Russian Federation
Facility Name
Teva Site 254
City
Saint Petersburg
Country
Russian Federation
Facility Name
Teva Site 255
City
Saint Petersburg
Country
Russian Federation
Facility Name
Teva Site 256
City
Saint Petersburg
Country
Russian Federation
Facility Name
Teva Site 257
City
Saint Petersburg
Country
Russian Federation
Facility Name
Teva Site 234
City
Yaroslavl
Country
Russian Federation
Facility Name
Teva Site 258
City
Yaroslavl
Country
Russian Federation
Facility Name
Teva Site 238
City
Bratislava
Country
Slovakia
Facility Name
Teva Site 242
City
Bratislava
Country
Slovakia
Facility Name
Teva Site 237
City
Hlohovec
Country
Slovakia
Facility Name
Teva Site 240
City
Lubochna
Country
Slovakia
Facility Name
Teva Site 241
City
Lučenec
Country
Slovakia
Facility Name
Teva Site 239
City
Prešov
Country
Slovakia
Facility Name
Teva Site 244
City
Kyiv
Country
Ukraine
Facility Name
Teva Site 245
City
Kyiv
Country
Ukraine
Facility Name
Teva Site 247
City
Kyiv
Country
Ukraine
Facility Name
Teva Site 248
City
Kyiv
Country
Ukraine
Facility Name
Teva Site 249
City
Kyiv
Country
Ukraine
Facility Name
Teva Site 243
City
Vinnytsia
Country
Ukraine
Facility Name
Teva Site 246
City
Zaporizhia
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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