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

Phase 3

Completed

• Conditions: Osteoporosis, Postmenopausal

• 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.

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-28
• Study Start: 2021-03-22
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-19
• Results First Submitted: 2024-01-04
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Results First Posted: 2024-04-18
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 332

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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

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