A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis

Teva Pharmaceuticals USA332 enrolled

Overview

The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

332

Conditions

Osteoporosis, Postmenopausal

Interventions

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)

Eligibility

Sex: FEMALEMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (78)

Outcomes

Primary Outcomes

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

Time frame: Baseline and week 52

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, week 26

Percent Change From Baseline in sCTX-1

Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen

Time frame: 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

Data from ClinicalTrials.gov

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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

...and 68 more locations

Percent Change From Baseline in P1NP

Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52

Time frame: Baseline through Week 52

Number of Fractures up to Week 52

Number of patients with who experienced any new fractures up to week 52.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: Week 52 through week 78

Incidence of Adverse Event

Number of patients reporting at least one treatment-emergent adverse event up to week 52

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52