Clinical trial NCT04729621: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2021-01-28
Enrollment: 332
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change From Baseline in LS-BMD at Week 52
timeFrame: Baseline and week 52
Secondary outcomes:
measure: Percent Change From Baseline in sCTX-1 at Week 26
timeFrame: Baseline and week 26
measure: Percent Change From Baseline in LS-BMD at Week 26
timeFrame: Baseline and week 26
measure: Percent Change From Baseline in Femoral Neck BMD at Week 26
timeFrame: Baseline, week 26
measure: Percent Change From Baseline in Total Hip BMD at Week 26
timeFrame: Baseline, week 26
measure: Percent Change From Baseline in sCTX-1
timeFrame: Baseline through Week 52
measure: Percentage of Participatns With sCTX-1 Suppression at Week 4
timeFrame: Week 4
measure: Percent Change From Baseline in P1NP
timeFrame: Baseline through Week 52
measure: Number of Fractures up to Week 52
timeFrame: Up to week 52
measure: Percent Change From Week 52 in LS-BMD by DXA at Week 78
timeFrame: Week 52 through week 78
measure: Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78
timeFrame: Week 52 through week 78
measure: Percent Change From Week 52 in Total Hip BMD by DXA at Week 78
timeFrame: Week 52 through week 78
measure: Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78
timeFrame: Baseline, Week 52, Week 78
measure: Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78
timeFrame: Baseline, Week 52, Week 78
measure: Number of Patients With Fractures Between Week 52 and Week 78
timeFrame: Week 52 through week 78
measure: Incidence of Adverse Event
timeFrame: Up to week 52
measure: Incidence of Adverse Events in the Transition Period
timeFrame: Week 52 through week 78
measure: Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
timeFrame: Anytime Post Baseline through Week 52
measure: Incidence of Antidrug Antibodies (ADAs) in the Transition Period
timeFrame: Anytime in Week 52 through Week 78
measure: Percent Change From Baseline in Femoral Neck BMD at Week 52
timeFrame: Baseline through Week 52
measure: Percent Change From Baseline in Total Hip BMD at Week 52
timeFrame: Baseline through Week 52
measure: Number of TEAEs Leading to Patient Withdraw From the Study
timeFrame: Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78
measure: Local Tolerability at Injection Site
timeFrame: Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Site 103
state: Arizona
city: Tucson
country: United States
facility: Teva Site 119
state: Arizona
city: San Diego
country: United States
facility: Teva Site 118
state: California
city: New London
country: United States
facility: Teva Site 107
state: Connecticut
city: Coral Gables
country: United States
facility: Teva Site 115
state: Florida
city: Edgewater
country: United States
facility: Teva Site 114
state: Florida
city: Lake City
country: United States
facility: Teva Site 116
state: Florida
city: Miami Lakes
country: United States
facility: Teva Site 109
state: Florida
city: Miami Springs
country: United States
facility: Teva Site 117
state: Florida
city: Oldsmar
country: United States
facility: Teva Site 110
state: Florida
city: Orlando
country: United States
facility: Teva Site 120
state: Florida
city: Ormond Beach
country: United States
facility: Teva Site 102
state: Florida
city: Port Saint Lucie
country: United States
facility: Teva Site 101
state: Florida
city: Sarasota
country: United States
facility: Teva Site 111
state: Florida
city: Tamarac
country: United States
facility: Teva Site 104
state: Florida
city: Henderson
country: United States
facility: Teva Site 112
state: Nevada
city: North Las Vegas
country: United States
facility: Teva Site 113
state: Nevada
city: Albuquerque
country: United States
facility: Teva Site 105
state: New Mexico
city: Duncansville
country: United States
facility: Teva Site 108
state: Pennsylvania
city: Seattle
country: United States
facility: Teva Site 106
state: Washington
city: Blagoevgrad
country: Bulgaria
facility: Teva Site 203
city: Dimitrovgrad
country: Bulgaria
facility: Teva Site 207
city: Haskovo
country: Bulgaria
facility: Teva Site 252
city: Lom
country: Bulgaria
facility: Teva Site 202
city: Plovdiv
country: Bulgaria
facility: Teva Site 205
city: Silistra
country: Bulgaria
facility: Teva Site 250
city: Sofia
country: Bulgaria
facility: Teva Site 201
city: Sofia
country: Bulgaria
facility: Teva Site 204
city: Sofia
country: Bulgaria
facility: Teva Site 251
city: Stara Zagora
country: Bulgaria
facility: Teva Site 206
city: Brno
country: Czechia
facility: Teva Site 211
city: Ostrava
country: Czechia
facility: Teva Site 213
city: Pardubice
country: Czechia
facility: Teva Site 212
city: Praha
country: Czechia
facility: Teva Site 209
city: Praha
country: Czechia
facility: Teva Site 210
city: Uherské Hradiště
country: Czechia
facility: Teva Site 208
city: Tbilisi
country: Georgia
facility: Teva Site 214
city: Tbilisi
country: Georgia
facility: Teva Site 215
city: Tbilisi
country: Georgia
facility: Teva Site 216
city: Tbilisi
country: Georgia
facility: Teva Site 217
city: Tbilisi
country: Georgia
facility: Teva Site 218
city: Tbilisi
country: Georgia
facility: Teva Site 219
city: Dresden
country: Germany
facility: Teva Site 223
city: Hamburg
country: Germany
facility: Teva Site 220
city: Numbrecht
country: Germany
facility: Teva Site 221
city: Würzburg
country: Germany
facility: Teva Site 222
city: Balatonfüred
country: Hungary
facility: Teva Site 226
city: Budapest
country: Hungary
facility: Teva Site 225
city: Budapest
country: Hungary
facility: Teva Site 227
city: Budapest
country: Hungary
facility: Teva Site 253
city: Nyiregyhaza
country: Hungary
facility: Teva Site 224
city: Białystok
country: Poland
facility: Teva Site 228
city: Kraków
country: Poland
facility: Teva Site 233
city: Warsaw
country: Poland
facility: Teva Site 230
city: Warsaw
country: Poland
facility: Teva Site 232
city: Wrocław
country: Poland
facility: Teva Site 229
city: Łódź
country: Poland
facility: Teva Site 231
city: Moscow
country: Russian Federation
facility: Teva Site 235
city: Saint Petersburg
country: Russian Federation
facility: Teva Site 236
city: Saint Petersburg
country: Russian Federation
facility: Teva Site 254
city: Saint Petersburg
country: Russian Federation
facility: Teva Site 255
city: Saint Petersburg
country: Russian Federation
facility: Teva Site 256
city: Saint Petersburg
country: Russian Federation
facility: Teva Site 257
city: Yaroslavl
country: Russian Federation
facility: Teva Site 234
city: Yaroslavl
country: Russian Federation
facility: Teva Site 258
city: Bratislava
country: Slovakia
facility: Teva Site 238
city: Bratislava
country: Slovakia
facility: Teva Site 242
city: Hlohovec
country: Slovakia
facility: Teva Site 237
city: Lubochna
country: Slovakia
facility: Teva Site 240
city: Lučenec
country: Slovakia
facility: Teva Site 241
city: Prešov
country: Slovakia
facility: Teva Site 239
city: Kyiv
country: Ukraine
facility: Teva Site 244
city: Kyiv
country: Ukraine
facility: Teva Site 245
city: Kyiv
country: Ukraine
facility: Teva Site 247
city: Kyiv
country: Ukraine
facility: Teva Site 248
city: Kyiv
country: Ukraine
facility: Teva Site 249
city: Vinnytsia
country: Ukraine
facility: Teva Site 243
city: Zaporizhia
country: Ukraine
facility: Teva Site 246
Study officials:
affiliation: Teva Pharmaceuticals, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: