Phase 3 N=332 Randomized Quadruple-blind Treatment

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

Osteoporosis, Postmenopausal

Bottom Line

View on ClinicalTrials.gov: NCT04729621 ↗

Enrolled (actual)

332

Serious AEs

3.2%

Results posted

Apr 2024

Primary outcome: Primary: Percent Change From Baseline in LS-BMD at Week 52 — 4.76; 4.54 percentage of change from baseline

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TVB-009 (Combination_product); Prolia® (Combination_product)
Age: Adult, Older Adult · 60+ yrs
Sex: Female
Sponsor: Teva Pharmaceuticals USA
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in LS-BMD at Week 52	4.76; 4.54	—
SECONDARY Percent Change From Baseline in sCTX-1 at Week 26	-56.05; -65.13	—
SECONDARY Percent Change From Baseline in LS-BMD at Week 26	3.70; 3.62	—
SECONDARY Percent Change From Baseline in Femoral Neck BMD at Week 26	1.87; 2.01	—
SECONDARY Percent Change From Baseline in Total Hip BMD at Week 26	1.89; 2.02	—
SECONDARY Percent Change From Baseline in sCTX-1	-57.91; -68.80	—
SECONDARY Percentage of Participatns With sCTX-1 Suppression at Week 4	94.2; 94.0	—
SECONDARY Percent Change From Baseline in P1NP	-56.43; -62.03	—
SECONDARY Number of Fractures up to Week 52	3; 5	—
SECONDARY Percent Change From Week 52 in LS-BMD by DXA at Week 78	0.82; 1.15; 1.24	—
SECONDARY Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78	0.38; 0.80; 0.94	—
SECONDARY Percent Change From Week 52 in Total Hip BMD by DXA at Week 78	0.01; 0.66; 0.27	—
SECONDARY Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78	9.95; 13.17; 7.55	—
SECONDARY Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78	3.95; 4.83; 2.89	—
SECONDARY Number of Patients With Fractures Between Week 52 and Week 78	1; 0; 1	—
SECONDARY Incidence of Adverse Event	19; 13; 0; 0; 104; 95	—
SECONDARY Incidence of Adverse Events in the Transition Period	2; 0; 0; 0; 0; 0	—
SECONDARY Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period	11; 25; 8; 11; 147; 129	—
SECONDARY Incidence of Antidrug Antibodies (ADAs) in the Transition Period	7; 5; 4; 7; 4; 1	—
SECONDARY Percent Change From Baseline in Femoral Neck BMD at Week 52	2.39; 2.34	—
SECONDARY Percent Change From Baseline in Total Hip BMD at Week 52	2.67; 3.00	—
SECONDARY Number of TEAEs Leading to Patient Withdraw From the Study	3; 7; 0; 0; 0	—
SECONDARY Local Tolerability at Injection Site	5; 4; 4; 2; 2; 3	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04729621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.