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
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
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.
Bone Loss, Post Menopausal Osteoporosis
Lactobacillus Acidophilus and Postmenopausal Women
This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.
- Conditions
- Bone Loss, Post Menopausal Osteoporosis, Mineralization
- Trial name
- LaBon (NCT05332626)
- Testing
- Probiotic group
- Where
- Poland
- Volunteers
- 90 people
- Sponsor
- Poznan University of Life Sciences
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, Gut Microbiota
Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.
- Conditions
- Postmenopausal Osteoporosis, Gut Microbiota, Cardiovascular Diseases
- Trial name
- NCT04431960
- Testing
- blackcurrant (BC) extract
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
Osteoporosis, Postmenopausal, Diabetes Mellitus, Type 2
Effect of GLP-1 Receptor Agonists on Trabecular Bone Score
This study will help determine the effect of Glucagon Like Peptide-1 (GLP-1)receptor agonists on bone strength in postmenopausal women with type 2 diabetes mellitus (T2DM)
- Trial name
- NCT04964388
- Testing
- GLP-1 receptor agonist
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Mississippi Medical Center
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
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
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.
Postmenopausal Osteoporosis
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative…
- Trial name
- NCT05087030
- Testing
- RGB-14-P, Prolia®
- Where
- 59 sites in United States, Bulgaria and 6 more
- Volunteers
- 473 people
- Sponsor
- Gedeon Richter Plc.
Osteoporosis, Postmenopausal, Osteoporosis
Preventing Osteoporosis Using Denosumab
The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and…
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures
- Trial name
- PROUD (NCT02753283)
- Testing
- denosumab, Calcium and Vitamin D
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Susan L. Greenspan
Postmenopausal Osteoporosis
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
- Trial name
- FRAME (NCT01575834)
- Testing
- Romosozumab, Denosumab
- Where
- 218 sites in United States, Argentina and 22 more
- Volunteers
- 7,180 people
- Sponsor
- Amgen
Osteoporosis, Postmenopausal
A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)
This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.
- Trial name
- NCT01350934
- Testing
- alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus), Calcitriol, Calcium 500 mg
- Volunteers
- 219 people
- Sponsor
- Organon and Co
Postmenopausal Women With Osteoporosis
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
- Trial name
- NCT04757376
- Testing
- CT-P41, US-licensed Prolia
- Where
- 20 sites in Estonia, Latvia and 2 more
- Volunteers
- 479 people
- Sponsor
- Celltrion
Postmenopausal Osteoporosis
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis.
- Trial name
- NCT00529373
- Testing
- Odanacatib, Vitamin D3, Calcium carbonate
- Volunteers
- 16,071 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoporosis Postmenopausal
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
To demonstrate the efficacy/safety of Fosamax Plus D
- Trial name
- NCT00729651
- Testing
- alendronate sodium (+) cholecalciferol, Comparator: Alendronate sodium (Fosamax), Comparator: Calcium
- Volunteers
- 343 people
- Sponsor
- Organon and Co
Osteoporosis, Postmenopausal
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual…
- Trial name
- NCT01416194
- Testing
- Bazedoxifene, Bisphosphonate, Raloxifene
- Volunteers
- 10,497 people
- Sponsor
- Pfizer