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Monoclonal Antibodies

TVB-009 for Osteoporosis

Phase 3
Waitlist Available
Research Sponsored by Teva Pharmaceuticals USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up main treatment period = baseline-week 52; transition period = week 52-78
Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of a new osteoporosis drug, TVB-009, to Prolia®.

Eligible Conditions
  • Postmenopausal Osteoporosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~main treatment period = baseline-week 52; transition period = week 52-78
This trial's timeline: 3 weeks for screening, Varies for treatment, and main treatment period = baseline-week 52; transition period = week 52-78 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in LS-BMD at Week 52
Secondary outcome measures
Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78
Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78
Incidence of Adverse Event
+19 more

Side effects data

From 2023 Phase 3 trial • 332 Patients • NCT04729621
20%
Vitamin D deficiency
10%
COVID-19
10%
Headache
8%
Hypercalcaemia
8%
Arthralgia
6%
Vitamin D decreased
5%
Hypertension
5%
Back pain
4%
Nasopharyngitis
4%
Urinary tract infection
4%
Pain in extremity
3%
Upper respiratory tract infection
2%
Spinal pain
1%
Bile duct stone
1%
Hepatitis C
1%
Peripheral arterial occlusive disease
1%
Dyslipidaemia
1%
Adrenal mass
1%
Cholelithiasis
1%
Infective periostitis
1%
Gastric neoplasm
1%
Abdominal pain upper
1%
Ureterolithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TVB-009 Main Treatment Period
PROLIA Main Treatment Period
TVB-009 Main / TVB-009 Transition Period
PROLIA Main / PROLIA Transition Period
PROLIA Main / TVB-009 Transition Period

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: TVB-009 main treatment periodExperimental Treatment1 Intervention
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
Group II: TVB-009 main / TVB-009 transition periodExperimental Treatment1 Intervention
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period
Group III: PROLIA main / TVB-009 transition periodExperimental Treatment2 Interventions
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Group IV: PROLIA main / PROLIA transition periodActive Control1 Intervention
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Group V: PROLIA main treatment periodActive Control1 Intervention
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TVB-009
2021
Completed Phase 3
~340
Prolia®
2019
Completed Phase 3
~1250

Find a Location

Who is running the clinical trial?

Teva Pharmaceuticals USALead Sponsor
230 Previous Clinical Trials
187,876 Total Patients Enrolled
Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor
251 Previous Clinical Trials
3,485,044 Total Patients Enrolled
Peter Bias, MDStudy DirectorTeva Branded Pharmaceuticals Products R&D, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the screening criteria for this research project?

"This trial is for postmenopausal women over the age of 60 and under 90 who have been diagnosed with osteoporosis. Patients must also meet the following criteria: Body weight between 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)."

Answered by AI

Are people still able to enroll in this research study?

"This study is not actively recruiting patients at this time, according to the latest information on clinicaltrials.gov. The trial was first posted on March 22nd 2021 and was last updated on December 16th 2021. There are 191 other clinical trials currently recruiting patients."

Answered by AI

Could you please contrast the results of this study with others in the same field?

"Currently, there are 49 active studies investigating TVB-009. This medication is in Phase 3 for 13 of those trials. Most of the research for TVB-009 occurs in Nedlands, Western Australia; however, 539 locations worldwide are studying this treatment."

Answered by AI

What is the current status of TVB-009 in terms of federal approval?

"There is both preclinical and clinical evidence supporting TVB-009's safety, thus it received a score of 3."

Answered by AI

For what purpose is TVB-009 most often prescribed?

"TVB-009 can be used to treat mature bones, bone growth, and conditions related to excess Androgens."

Answered by AI

Does this experiment exclude elderly individuals?

"This particular study is only for patients aged 60 to 90. However, there are 20 other clinical trials for patients who are younger and 163 for those who are older."

Answered by AI

How many guinea pigs are participating in this experiment?

"Although this trial was last updated on December 16th, 2021, it is not currently recruiting patients. There are 142 other clinical trials for osteoporosis and 49 for TVB-009 that are still open to new participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
2021. "A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04729621.
~83 spots leftby Apr 2025
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