Clinical trials: Osteoporosis Postmenopausal
Postmenopausal Osteoporosis
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.
- Trial name
- NCT06079476
- Testing
- Romosozumab
- Where
- 10 sites in India
- Volunteers
- 100 people
- Sponsor
- Amgen
Post Menopausal Osteoporosis
Evaluation of Adherence With Bisphosphonates and Calcium and Vitamin D Supplements in Women With Postmenopausal Osteoporosis
This study aims to evaluate the adherence of patients to combined treatment with bisphosphonates and calcium and vitamin D supplements, which is one of the usual treatments for postmenopausal osteoporosis.
- Trial name
- OSTEOAD (NCT07105163)
- Where
- 20 sites in Spain
- Volunteers
- 230 people
- Sponsor
- Procare Health Iberia S.L.
Osteoporosis, Postmenopausal
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
- Trial name
- NCT04729621
- Testing
- TVB-009, Prolia®
- Where
- 78 sites in United States, Bulgaria and 8 more
- Volunteers
- 332 people
- Sponsor
- Teva Pharmaceuticals USA
Postmenopausal Osteoporosis, Low Bone Mass
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
This is a randomized, double-blind, placebo- and active-controlled Phase II study evaluating the efficacy and safety of TST002 injection (a humanized monoclonal antibody) in postmenopausal women with osteoporosis or low bone…
- Trial name
- NCT07806331
- Testing
- Denosumab
- Volunteers
- 110 people
- Sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
Postmenopausal Women Osteoporosis
A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis
This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with…
- Trial name
- NCT06804590
- Testing
- 9MW0311, Prolia®
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Postmenopausal Women With Osteoporosis
A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens
This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.
- Trial name
- NCT07579936
- Testing
- SAL056 56.5μg, Intervention Group 1, Intervention Group 2
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Osteoporosis, Postmenopausal, Bone Density, Low
The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women
Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures.
- Trial name
- NCT06375668
- Testing
- Probiotic
- Where
- 3 sites in Poland
- Volunteers
- 170 people
- Sponsor
- Nordic Biotic Sp. z o.o.
Postmenopausal Osteoporosis
A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®
The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis.
- Trial name
- NCT05405725
- Testing
- ENZ215, Prolia
- Where
- 48 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 504 people
- Sponsor
- Enzene Biosciences Ltd.
Postmenopausal Osteoporosis
A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.
- Trial name
- ARTEMIS (NCT06577935)
- Testing
- AGA2118
- Where
- 23 sites in United States, Argentina and 2 more
- Volunteers
- 379 people
- Sponsor
- Angitia Biopharmaceuticals
Postmenopausal Women With Osteoporosis
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with…
- Trial name
- DEVOTE (NCT05345691)
- Testing
- Bmab 1000, Prolia®
- Where
- United Kingdom
- Volunteers
- 479 people
- Sponsor
- Biocon Biologics UK Ltd
Postmenopausal Osteoporosis
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year
- Trial name
- NCT05630768
- Testing
- Risedronate Sodium 35 MG [Actonel], Calcium Vitamin D combination
- Where
- South Korea
- Volunteers
- 149 people
- Sponsor
- Dong-A ST Co., Ltd.
Postmenopausal Women With Osteoporosis at High Risk of Fracture
A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
This study is a multicenter, randomized, double-blind comparative study to valuating the efficacy and safety of QL1206 and Prolia® in postmenopausal women with osteoporosis at high risk of fracture.
- Trial name
- NCT07062978
- Testing
- QL1206, Prolia®
- Where
- China
- Volunteers
- 278 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Postmenopausal Women With Osteoporosis
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk
- Trial name
- NCT07028320
- Testing
- SAL056 (56.5μg), Alendronate
- Where
- China
- Volunteers
- 493 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Osteoporosis, Postmenopausal
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in…
- Trial name
- ALVOBOND (NCT05395091)
- Testing
- AVT03, Denosumab
- Where
- 34 sites in Bulgaria, Czechia and 3 more
- Volunteers
- 532 people
- Sponsor
- Alvotech Swiss AG
Postmenopausal Women With Osteoporosis
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.
- Trial name
- NCT06898060
- Testing
- QLG2128, Teriparatide Injection
- Volunteers
- 282 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Postmenopausal Women With Osteoporosis
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with…
- Trial name
- NCT05338086
- Testing
- MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium
- Where
- 64 sites in Bulgaria, Estonia and 6 more
- Volunteers
- 558 people
- Sponsor
- mAbxience Research S.L.
Postmenopausal Osteoporosis
A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis
The primary objective of this study is to demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).
- Trial name
- NCT04934072
- Testing
- FKS518, US-licensed Prolia (Amgen)
- Where
- 76 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 553 people
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Postmenopausal Women With Osteoporosis
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
- Trial name
- ARCH (NCT01631214)
- Testing
- Romosozumab, Alendronate
- Where
- 316 sites in United States, Argentina and 40 more
- Volunteers
- 4,093 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .
evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
- Trial name
- NCT04591275
- Testing
- CMAB807 Injection, Prolia®
- Where
- China
- Volunteers
- 278 people
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
Postmenopausal Osteoporosis
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
- Trial name
- NCT04664959
- Testing
- SB16 (Proposed Denosumab Biosimilar), Prolia® (Denosumab)
- Where
- 5 sites in Poland
- Volunteers
- 457 people
- Sponsor
- Samsung Bioepis Co., Ltd.