A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- Combination Product: TVB-009Combination Product: Prolia®
- Registration Number
- NCT04729621
- Lead Sponsor
- Teva Pharmaceuticals USA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 332
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TVB-009 main treatment period TVB-009 TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 PROLIA main / TVB-009 transition period TVB-009 TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period PROLIA main treatment period Prolia® Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009 main / TVB-009 transition period TVB-009 TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period PROLIA main / PROLIA transition period Prolia® Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period PROLIA main / TVB-009 transition period Prolia® TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in LS-BMD at Week 52 Baseline and 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
Name Time Method Percent Change From Baseline in sCTX-1 at Week 26 Baseline and 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 Baseline and 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 Baseline, 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 sCTX-1 Baseline through Week 52 Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen
Percent Change From Baseline in Total Hip BMD at Week 26 Baseline, 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 P1NP Baseline through Week 52 Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52
Percent Change From Week 52 in LS-BMD by DXA at Week 78 Week 52 through 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 Week 52 through 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 Week 52 through 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
Percentage of Participatns With sCTX-1 Suppression at Week 4 Week 4 Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4
Incidence of Antidrug Antibodies (ADAs) in the Transition Period Anytime in Week 52 through Week 78 Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65
Percent Change From Baseline in Femoral Neck BMD at Week 52 Baseline through 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
Number of Fractures up to Week 52 Up to week 52 Number of patients with who experienced any new fractures up to week 52.
Incidence of Adverse Events in the Transition Period Week 52 through week 78 Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78
Percent Change From Baseline in Total Hip BMD at Week 52 Baseline through 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 Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78 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 Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52 Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52.
Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78 Baseline, Week 52, 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 Baseline, Week 52, 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 Week 52 through week 78 Number of patients experiencing new fractures between week 52 and week 78
Incidence of Adverse Event Up to week 52 Number of patients reporting at least one treatment-emergent adverse event up to week 52
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period Anytime Post Baseline through Week 52 Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52
Trial Locations
- Locations (78)
Teva Site 107
🇺🇸New London, Connecticut, United States
Teva Site 119
🇺🇸Tucson, Arizona, 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 117
🇺🇸Miami Springs, Florida, United States
Teva Site 102
🇺🇸Ormond Beach, Florida, United States
Teva Site 110
🇺🇸Oldsmar, Florida, United States
Teva Site 120
🇺🇸Orlando, Florida, United States
Teva Site 101
🇺🇸Port Saint Lucie, Florida, United States
Teva Site 104
🇺🇸Tamarac, Florida, United States
Teva Site 112
🇺🇸Henderson, Nevada, United States
Teva Site 105
🇺🇸Albuquerque, New Mexico, United States
Teva Site 108
🇺🇸Duncansville, Pennsylvania, United States
Teva Site 252
🇧🇬Haskovo, Bulgaria
Teva Site 203
🇧🇬Blagoevgrad, Bulgaria
Teva Site 207
🇧🇬Dimitrovgrad, Bulgaria
Teva Site 202
🇧🇬Lom, Bulgaria
Teva Site 250
🇧🇬Silistra, Bulgaria
Teva Site 251
🇧🇬Sofia, Bulgaria
Teva Site 211
🇨🇿Brno, Czechia
Teva Site 212
🇨🇿Pardubice, Czechia
Teva Site 213
🇨🇿Ostrava, Czechia
Teva Site 209
🇨🇿Praha, Czechia
Teva Site 210
🇨🇿Praha, Czechia
Teva Site 208
🇨🇿Uherské Hradiště, Czechia
Teva Site 220
🇩🇪Hamburg, Germany
Teva Site 223
🇩🇪Dresden, Germany
Teva Site 221
🇩🇪Numbrecht, Germany
Teva Site 222
🇩🇪Würzburg, Germany
Teva Site 226
🇭🇺Balatonfüred, Hungary
Teva Site 233
🇵🇱Kraków, Poland
Teva Site 231
🇵🇱Łódź, Poland
Teva Site 236
🇷🇺Saint Petersburg, Russian Federation
Teva Site 235
🇷🇺Moscow, Russian Federation
Teva Site 254
🇷🇺Saint Petersburg, Russian Federation
Teva Site 256
🇷🇺Saint Petersburg, Russian Federation
Teva Site 234
🇷🇺Yaroslavl, Russian Federation
Teva Site 255
🇷🇺Saint Petersburg, Russian Federation
Teva Site 257
🇷🇺Saint Petersburg, Russian Federation
Teva Site 258
🇷🇺Yaroslavl, Russian Federation
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 243
🇺🇦Vinnytsia, Ukraine
Teva Site 246
🇺🇦Zaporizhia, Ukraine
Teva Site 249
🇺🇦Kyiv, Ukraine
Teva Site 253
🇭🇺Budapest, Hungary
Teva Site 205
🇧🇬Plovdiv, Bulgaria
Teva Site 227
🇭🇺Budapest, Hungary
Teva Site 217
🇬🇪Tbilisi, Georgia
Teva Site 218
🇬🇪Tbilisi, Georgia
Teva Site 240
🇸🇰Lubochna, Slovakia
Teva Site 241
🇸🇰Lučenec, Slovakia
Teva Site 214
🇬🇪Tbilisi, Georgia
Teva Site 216
🇬🇪Tbilisi, Georgia
Teva Site 237
🇸🇰Hlohovec, Slovakia
Teva Site 201
🇧🇬Sofia, Bulgaria
Teva Site 204
🇧🇬Sofia, Bulgaria
Teva Site 206
🇧🇬Stara Zagora, Bulgaria
Teva Site 215
🇬🇪Tbilisi, Georgia
Teva Site 219
🇬🇪Tbilisi, Georgia
Teva Site 224
🇭🇺Nyiregyhaza, Hungary
Teva Site 228
🇵🇱Białystok, Poland
Teva Site 232
🇵🇱Warsaw, Poland
Teva Site 230
🇵🇱Warsaw, Poland
Teva Site 238
🇸🇰Bratislava, Slovakia
Teva Site 229
🇵🇱Wrocław, Poland
Teva Site 242
🇸🇰Bratislava, Slovakia
Teva Site 111
🇺🇸Sarasota, Florida, United States
Teva Site 113
🇺🇸North Las Vegas, Nevada, United States
Teva Site 103
🇺🇸Phoenix, Arizona, United States
Teva Site 118
🇺🇸San Diego, California, United States
Teva Site 109
🇺🇸Miami Lakes, Florida, United States
Teva Site 106
🇺🇸Seattle, Washington, United States
Teva Site 225
🇭🇺Budapest, Hungary