Osteoporosis, PostmenopausalPhase 3NCT04729621
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
A Phase 3 study testing TVB-009 and Prolia® in people with Osteoporosis, Postmenopausal, run by Teva Pharmaceuticals USA at 78 sites in 10 countries.
Trial summary
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab) Read more about this study
- Who is it for?
- Ages 60 to 90 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- TVB-009 and Prolia®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 78 sitesin 10 countries
- Study dates
- 22 Mar 2021to 19 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
78 sites in 10 countries.
78 sites in 10 countries
United States20 sites
Teva Site 105
Albuquerque, New Mexico, 87106
Teva Site 115
Coral Gables, Florida, 33134
Teva Site 108
Duncansville, Pennsylvania, 16635
Teva Site 114
Edgewater, Florida, 32132
Teva Site 112
Henderson, Nevada, 89014
Teva Site 116
Lake City, Florida, 32055
Teva Site 109
Miami Lakes, Florida, 33014
Teva Site 117
Miami Springs, Florida, 33166
Teva Site 107
New London, Connecticut, 06320
Teva Site 113
North Las Vegas, Nevada, 89030
Teva Site 110
Oldsmar, Florida, 34677
Teva Site 120
Orlando, Florida, 32801
Teva Site 102
Ormond Beach, Florida, 32174
Teva Site 103
Phoenix, Arizona, 85004
Teva Site 101
Port Saint Lucie, Florida, 34952
Teva Site 118
San Diego, California, 92111
Teva Site 111
Sarasota, Florida, 34239
Teva Site 106
Seattle, Washington, 98105
Teva Site 104
Tamarac, Florida, 33321
Teva Site 119
Tucson, Arizona, 85704
Bulgaria10 sites
Teva Site 203
Blagoevgrad
Teva Site 207
Dimitrovgrad
Teva Site 252
Haskovo
Teva Site 202
Lom
Teva Site 205
Plovdiv
Teva Site 250
Silistra
Teva Site 201
Sofia
Teva Site 204
Sofia
Teva Site 251
Sofia
Teva Site 206
Stara Zagora
Russia8 sites
Teva Site 235
Moscow
Teva Site 236
Saint Petersburg
Teva Site 254
Saint Petersburg
Teva Site 255
Saint Petersburg
Teva Site 256
Saint Petersburg
Teva Site 257
Saint Petersburg
Teva Site 234
Yaroslavl
Teva Site 258
Yaroslavl
Ukraine7 sites
Teva Site 244
Kyiv
Teva Site 245
Kyiv
Teva Site 247
Kyiv
Teva Site 248
Kyiv
Teva Site 249
Kyiv
Teva Site 243
Vinnytsia
Teva Site 246
Zaporizhia
Czechia6 sites
Teva Site 211
Brno
Teva Site 213
Ostrava
Teva Site 212
Pardubice
Teva Site 209
Prague
Teva Site 210
Prague
Teva Site 208
Uherské Hradiště
Georgia6 sites
Teva Site 214
Tbilisi
Teva Site 215
Tbilisi
Teva Site 216
Tbilisi
Teva Site 217
Tbilisi
Teva Site 218
Tbilisi
Teva Site 219
Tbilisi
Poland6 sites
Teva Site 228
Bialystok
Teva Site 233
Krakow
Teva Site 231
Lodz
Teva Site 230
Warsaw
Teva Site 232
Warsaw
Teva Site 229
Wroclaw
Slovakia6 sites
Teva Site 238
Bratislava
Teva Site 242
Bratislava
Teva Site 237
Hlohovec
Teva Site 240
Ľubochňa
Teva Site 241
Lučenec
Teva Site 239
Prešov
Hungary5 sites
Teva Site 226
Balatonfüred
Teva Site 225
Budapest
Teva Site 227
Budapest
Teva Site 253
Budapest
Teva Site 224
Nyíregyháza
Germany4 sites
Teva Site 223
Dresden
Teva Site 220
Hamburg
Teva Site 221
Nümbrecht
Teva Site 222
Würzburg
About this study
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
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- TVB-009, Prolia®
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVB-009Combination product
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®Combination product
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| TVB-009 main treatment period | Experimental | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 Receives: Combination Product: TVB-009 |
| PROLIA main treatment period | Active comparator | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Receives: 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 Receives: 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 Receives: 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 Receives: Combination Product: TVB-009; Combination Product: Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and week 52
Secondary outcomes (22)
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
Measured: Baseline and 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
Measured: Baseline and week 26
Percent Change From Baseline in Femoral Neck BMD at 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
Measured: Baseline, week 26
Percent Change From Baseline in Total Hip BMD at 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
Measured: Baseline, week 26
Percent Change From Baseline in sCTX-1
Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen
Measured: Baseline through Week 52
Percentage of Participatns With sCTX-1 Suppression at Week 4
Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4
Measured: Week 4
Percent Change From Baseline in P1NP
Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52
Measured: Baseline through Week 52
Number of Fractures up to Week 52
Number of patients with who experienced any new fractures up to week 52.
Measured: 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
Measured: Week 52 through 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
Measured: Week 52 through 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
Measured: Week 52 through week 78
Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and 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
Measured: Baseline, Week 52, Week 78
Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78
The difference in the Percent change from baseline in procollagen type 1 N propeptide at Week 78 compared to Week 52.
Measured: Baseline, Week 52, Week 78
Number of Patients With Fractures Between Week 52 and Week 78
Number of patients experiencing new fractures between week 52 and week 78
Measured: Week 52 through week 78
Incidence of Adverse Event
Number of patients reporting at least one treatment-emergent adverse event up to week 52
Measured: 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
Measured: Week 52 through week 78
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52
Measured: Anytime Post Baseline through Week 52
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65
Measured: Anytime in Week 52 through Week 78
Percent Change From Baseline in Femoral Neck BMD at 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
Measured: Baseline through Week 52
Percent Change From Baseline in Total Hip BMD at 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
Measured: Baseline through Week 52
Number of TEAEs Leading to Patient Withdraw From the Study
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.
Measured: Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78
Local Tolerability at Injection Site
Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52.
Measured: Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start22 Mar 2021
- Primary completion31 Dec 2022
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729621
- Sponsor's protocol ID
- TVB009-IMB-30085
- Status last verified
- Sep 2026
- First submitted
- 25 Jan 2021
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04729621
- Acronym / sponsor ID
- TVB009-IMB-30085
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TVB-009 main treatment period | Experimental | Combination Product: TVB-009TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 |
| PROLIA main treatment period | Active comparator | Combination Product: Prolia®Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 |
| TVB-009 main / TVB-009 transition period | Experimental | Combination Product: TVB-009TVB-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 | Active comparator | Combination Product: 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 | Experimental | Combination Product: TVB-009, Combination Product: Prolia®TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVB-009TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | Combination product | PROLIA main / TVB-009 transition period, TVB-009 main / TVB-009 transition period, TVB-009 main treatment period |
| Prolia®Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | Combination product | PROLIA main / PROLIA transition period, PROLIA main / TVB-009 transition period, PROLIA main treatment period |
Primary outcome
Percent Change From Baseline in LS-BMD at Week 52
Time frame: 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
22 secondary outcomes
Percent Change From Baseline in sCTX-1 at Week 26
Time frame: Baseline and week 26
Percent Change From Baseline in LS-BMD at Week 26
Time frame: Baseline and week 26
Percent Change From Baseline in Femoral Neck BMD at Week 26
Time frame: Baseline, week 26
Percent Change From Baseline in Total Hip BMD at Week 26
Time frame: Baseline, week 26
Percent Change From Baseline in sCTX-1
Time frame: Baseline through Week 52
Percentage of Participatns With sCTX-1 Suppression at Week 4
Time frame: Week 4
Percent Change From Baseline in P1NP
Time frame: Baseline through Week 52
Number of Fractures up to Week 52
Time frame: Up to week 52
Percent Change From Week 52 in LS-BMD by DXA at Week 78
Time frame: Week 52 through week 78
Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78
Time frame: Week 52 through week 78
Percent Change From Week 52 in Total Hip BMD by DXA at Week 78
Time frame: Week 52 through week 78
Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78
Time frame: Baseline, Week 52, Week 78
Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78
Time frame: Baseline, Week 52, Week 78
Number of Patients With Fractures Between Week 52 and Week 78
Time frame: Week 52 through week 78
Incidence of Adverse Event
Time frame: Up to week 52
Incidence of Adverse Events in the Transition Period
Time frame: Week 52 through week 78
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
Time frame: Anytime Post Baseline through Week 52
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
Time frame: Anytime in Week 52 through Week 78
Percent Change From Baseline in Femoral Neck BMD at Week 52
Time frame: Baseline through Week 52
Percent Change From Baseline in Total Hip BMD at Week 52
Time frame: Baseline through Week 52
Number of TEAEs Leading to Patient Withdraw From the Study
Time frame: Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78
Local Tolerability at Injection Site
Time frame: Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Pharmaceuticals, Inc.
78 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TVB-009 and Prolia® in people with Osteoporosis, Postmenopausal, run by Teva Pharmaceuticals USA at 78 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Bulgaria, Russia, Ukraine, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in LS-BMD at Week 52 (time frame: Baseline and week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.