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

Completed · Phase 3

Conditions studied: Osteoporosis, Postmenopausal

In brief

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

Key facts

Study ID

NCT04729621

Run by

Teva Pharmaceuticals USA

People needed

332

Starts

2021-03-22

Expected to finish

2023-06-19

Last updated by the study team

2024-04-18

Who can join

Age: 60 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• Teva Site 120 — Orlando, Florida, United States
• Teva Site 102 — Ormond Beach, Florida, United States
• Teva Site 101 — Port Saint Lucie, Florida, United States
• Teva Site 111 — Sarasota, Florida, United States
• Teva Site 104 — Tamarac, Florida, United States
• Teva Site 112 — Henderson, Nevada, United States
• Teva Site 113 — North Las Vegas, Nevada, United States
• Teva Site 105 — Albuquerque, New Mexico, United States
• Teva Site 108 — Duncansville, Pennsylvania, United States
• Teva Site 106 — Seattle, Washington, United States
• Teva Site 203 — Blagoevgrad, Bulgaria
• Teva Site 207 — Dimitrovgrad, Bulgaria
• Teva Site 252 — Haskovo, Bulgaria
• Teva Site 202 — Lom, Bulgaria
• Teva Site 205 — Plovdiv, Bulgaria
• Teva Site 103 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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