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A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
Sponsor: Teva Pharmaceuticals USA
Summary
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
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
Key Details
Gender
FEMALE
Age Range
60 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
332
Start Date
2021-03-22
Completion Date
2023-06-19
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
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 (78)
Teva Site 103
Phoenix, Arizona, United States
Teva Site 119
Tucson, Arizona, United States
Teva Site 118
San Diego, California, United States
Teva Site 107
New London, Connecticut, United States
Teva Site 115
Coral Gables, Florida, United States
Teva Site 114
Edgewater, Florida, 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 110
Oldsmar, Florida, United States
Teva Site 120
Orlando, Florida, United States
Teva Site 102
Ormond Beach, Florida, United States
Teva Site 101
Port Saint Lucie, Florida, United States
Teva Site 111
Sarasota, Florida, United States
Teva Site 104
Tamarac, Florida, United States
Teva Site 112
Henderson, Nevada, United States
Teva Site 113
North Las Vegas, Nevada, United States
Teva Site 105
Albuquerque, New Mexico, United States
Teva Site 108
Duncansville, Pennsylvania, United States
Teva Site 106
Seattle, Washington, United States
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, Bulgaria
Teva Site 211
Brno, Czechia
Teva Site 213
Ostrava, Czechia
Teva Site 212
Pardubice, Czechia
Teva Site 209
Prague, Czechia
Teva Site 210
Prague, Czechia
Teva Site 208
Uherské Hradiště, Czechia
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, Georgia
Teva Site 223
Dresden, Germany
Teva Site 220
Hamburg, Germany
Teva Site 221
Nümbrecht, Germany
Teva Site 222
Würzburg, Germany
Teva Site 226
Balatonfüred, Hungary
Teva Site 225
Budapest, Hungary
Teva Site 227
Budapest, Hungary
Teva Site 253
Budapest, Hungary
Teva Site 224
Nyíregyháza, Hungary
Teva Site 228
Bialystok, Poland
Teva Site 233
Krakow, Poland
Teva Site 231
Lodz, Poland
Teva Site 230
Warsaw, Poland
Teva Site 232
Warsaw, Poland
Teva Site 229
Wroclaw, Poland
Teva Site 235
Moscow, Russia
Teva Site 236
Saint Petersburg, Russia
Teva Site 254
Saint Petersburg, Russia
Teva Site 255
Saint Petersburg, Russia
Teva Site 256
Saint Petersburg, Russia
Teva Site 257
Saint Petersburg, Russia
Teva Site 234
Yaroslavl, Russia
Teva Site 258
Yaroslavl, Russia
Teva Site 238
Bratislava, Slovakia
Teva Site 242
Bratislava, Slovakia
Teva Site 237
Hlohovec, Slovakia
Teva Site 241
Lučenec, Slovakia
Teva Site 240
Ľubochňa, Slovakia
Teva Site 239
Prešov, Slovakia
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, Ukraine