A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TVB-009 main treatment period TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 |
Combination Product: TVB-009
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
| Active Comparator: PROLIA main treatment period Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 |
Combination Product: Prolia®
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
| Experimental: TVB-009 main / TVB-009 transition period 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
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
| Active Comparator: PROLIA main / PROLIA transition period Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period |
Combination Product: Prolia®
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
| Experimental: PROLIA main / TVB-009 transition period 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
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Combination Product: Prolia®
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 [Baseline, week 26, 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 26 and at week 52
- Percent change from baseline in total hip BMD [Baseline, week 26, 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 26 and at week 52
- 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
- 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
- Percent change from baseline in P1NP [Baseline, week 26, week 52]
Percent change from baseline in procollagen type 1 N propeptide (P1NP) at week 26 and week 52
- Incidence of fractures up to week 52 [Up to week 52]
Number of patients with fractures up 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
- Difference between percent change from baseline in sCTX-1 at weeks 52 and 78 [Week 52 through week 78]
Difference between percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at weeks 52 and 78
- Difference between percent change from baseline in P1NP at weeks 52 and 78 [Week 52 through week 78]
Difference between percent change from baseline in procollagen type 1 N propeptide at weeks 52 and 78
- Incidence of fractures between week 52 and week 78 [Week 52 through week 78]
Number of patients with fractures between week 52 and week 78
- Incidence of adverse event and withdrawals due to adverse events [Up to week 52]
Number of patients reporting at least one treatment-emergent adverse event 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
- Incidence of antidrug antibodies (ADAs) in the main treatment period [Up to week 52]
Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline up to week 52
- Incidence of antidrug antibodies (ADAs) in the transition period [Week 52 through week 78]
Number of patients with confirmed positive antidrug antibodies (ADAs) between week 52 and 78
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 10101 | Port Saint Lucie | Florida | United States | 34952 |
Sponsors and Collaborators
- Teva Pharmaceuticals USA
- Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
- Study Director: Peter Bias, MD, Teva Branded Pharmaceuticals Products R&D, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TVB009-IMB-30085