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

NCT04729621 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TVB009-IMB-30085
• Study Type: interventional
• Target: 332
• Locations: 10 countries
• Sites: 78

Brief Summary

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

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Percent Change From Baseline in sCTX-1 at Week 26

  Baseline and week 26

• Percent Change From Baseline in LS-BMD at Week 26

  Baseline and week 26

• Percent Change From Baseline in Femoral Neck BMD at Week 26

  Baseline, week 26

• Percent Change From Baseline in Total Hip BMD at Week 26

  Baseline, week 26

• Percent Change From Baseline in sCTX-1

  Baseline through Week 52

Study Arms (5)

TVB-009 main treatment period

EXPERIMENTAL

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

Combination Product: TVB-009

PROLIA main treatment period

ACTIVE COMPARATOR

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

Combination Product: Prolia®

TVB-009 main / TVB-009 transition period

EXPERIMENTAL

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

Combination Product: TVB-009

PROLIA main / PROLIA transition period

ACTIVE COMPARATOR

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

Combination Product: Prolia®

PROLIA main / TVB-009 transition period

EXPERIMENTAL

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

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

Interventions

TVB-009 COMBINATION_PRODUCT

TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

PROLIA main / TVB-009 transition period; TVB-009 main / TVB-009 transition period; TVB-009 main treatment period

Prolia® COMBINATION_PRODUCT

Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

PROLIA main / PROLIA transition period; PROLIA main / TVB-009 transition period; PROLIA main treatment period

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (78)

Teva Site 103

Phoenix, Arizona, 85004, United States

Location

Teva Site 119

Tucson, Arizona, 85704, United States

Location

Teva Site 118

San Diego, California, 92111, United States

Location

Teva Site 107

New London, Connecticut, 06320, United States

Location

Teva Site 115

Coral Gables, Florida, 33134, United States

Location

Teva Site 114

Edgewater, Florida, 32132, United States

Location

Teva Site 116

Lake City, Florida, 32055, United States

Location

Teva Site 109

Miami Lakes, Florida, 33014, United States

Location

Teva Site 117

Miami Springs, Florida, 33166, United States

Location

Teva Site 110

Oldsmar, Florida, 34677, United States

Location

Teva Site 120

Orlando, Florida, 32801, United States

Location

Teva Site 102

Ormond Beach, Florida, 32174, United States

Location

Teva Site 101

Port Saint Lucie, Florida, 34952, United States

Location

Teva Site 111

Sarasota, Florida, 34239, United States

Location

Teva Site 104

Tamarac, Florida, 33321, United States

Location

Teva Site 112

Henderson, Nevada, 89014, United States

Location

Teva Site 113

North Las Vegas, Nevada, 89030, United States

Location

Teva Site 105

Albuquerque, New Mexico, 87106, United States

Location

Teva Site 108

Duncansville, Pennsylvania, 16635, United States

Location

Teva Site 106

Seattle, Washington, 98105, United States

Location

Teva Site 203

Blagoevgrad, Bulgaria

Location

Teva Site 207

Dimitrovgrad, Bulgaria

Location

Teva Site 252

Haskovo, Bulgaria

Location

Teva Site 202

Lom, Bulgaria

Location

Teva Site 205

Plovdiv, Bulgaria

Location

Teva Site 250

Silistra, Bulgaria

Location

Teva Site 201

Sofia, Bulgaria

Location

Teva Site 204

Sofia, Bulgaria

Location

Teva Site 251

Sofia, Bulgaria

Location

Teva Site 206

Stara Zagora, Bulgaria

Location

Teva Site 211

Brno, Czechia

Location

Teva Site 213

Ostrava, Czechia

Location

Teva Site 212

Pardubice, Czechia

Location

Teva Site 209

Prague, Czechia

Location

Teva Site 210

Prague, Czechia

Location

Teva Site 208

Uherské Hradiště, Czechia

Location

Teva Site 214

Tbilisi, Georgia

Location

Teva Site 215

Tbilisi, Georgia

Location

Teva Site 216

Tbilisi, Georgia

Location

Teva Site 217

Tbilisi, Georgia

Location

Teva Site 218

Tbilisi, Georgia

Location

Teva Site 219

Tbilisi, Georgia

Location

Teva Site 223

Dresden, Germany

Location

Teva Site 220

Hamburg, Germany

Location

Teva Site 221

Nümbrecht, Germany

Location

Teva Site 222

Würzburg, Germany

Location

Teva Site 226

Balatonfüred, Hungary

Location

Teva Site 225

Budapest, Hungary

Location

Teva Site 227

Budapest, Hungary

Location

Teva Site 253

Budapest, Hungary

Location

Teva Site 224

Nyíregyháza, Hungary

Location

Teva Site 228

Bialystok, Poland

Location

Teva Site 233

Krakow, Poland

Location

Teva Site 231

Lodz, Poland

Location

Teva Site 230

Warsaw, Poland

Location

Teva Site 232

Warsaw, Poland

Location

Teva Site 229

Wroclaw, Poland

Location

Teva Site 235

Moscow, Russia

Location

Teva Site 236

Saint Petersburg, Russia

Location

Teva Site 254

Saint Petersburg, Russia

Location

Teva Site 255

Saint Petersburg, Russia

Location

Teva Site 256

Saint Petersburg, Russia

Location

Teva Site 257

Saint Petersburg, Russia

Location

Teva Site 234

Yaroslavl, Russia

Location

Teva Site 258

Yaroslavl, Russia

Location

Teva Site 238

Bratislava, Slovakia

Location

Teva Site 242

Bratislava, Slovakia

Location

Teva Site 237

Hlohovec, Slovakia

Location

Teva Site 241

Lučenec, Slovakia

Location

Teva Site 240

Ľubochňa, Slovakia

Location

Teva Site 239

Prešov, Slovakia

Location

Teva Site 244

Kyiv, Ukraine

Location

Teva Site 245

Kyiv, Ukraine

Location

Teva Site 247

Kyiv, Ukraine

Location

Teva Site 248

Kyiv, Ukraine

Location

Teva Site 249

Kyiv, Ukraine

Location

Teva Site 243

Vinnytsia, Ukraine

Location

Teva Site 246

Zaporizhia, Ukraine

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: US Medical Affairs
• Organization: Teva Pharmaceuticals

usmedinfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: March 22, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 19, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (6); PL (6); SL (6); CZ (6); UA (7); BU (10); HU (5); DE (4); RU (8); US (20)