Clinical trials: Osteoporosis
Osteoporosis, Osteopenia
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
The goal of this study is to assess the performance of an artificial intelligence software (Osteo Signal) in detecting osteoporosis risk in adults 50 years and older.
- Trial name
- NCT07421713
- Testing
- Osteo Signal
- Where
- 3 sites in Netherlands, United Kingdom
- Volunteers
- 595 people, healthy volunteers welcome
- Sponsor
- Promedius Inc
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
Osteoporosis
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar spine, at the total hip and femoral neck in…
- Trial name
- NCT05067335
- Testing
- Romosozumab
- Where
- 30 sites in China
- Volunteers
- 327 people
- Sponsor
- UCB Biopharma SRL
Healthy, Osteopenia
Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-BMD (NCT07187518)
- Testing
- Measurements with the POROUS R4C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine
- Where
- 2 sites in Germany
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
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.
Osteoporosis, Osteoarthritis
OSTEOMICS: Identifying Regulators of Bone Homeostasis
Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity.
- Conditions
- Osteoporosis, Osteoarthritis, Bone Diseases, Bone Fracture
- Trial name
- OSTEOMICS (NCT05732870)
- Testing
- Relevant orthopaedic surgery
- Where
- 8 sites in United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Relation Therapeutics
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.
Bone Tumor, Osteoporosis
U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.
- Conditions
- Bone Tumor, Osteoporosis, Traumatic Fracture
- Trial name
- EPIOS (NCT07325578)
- Testing
- Percutaneous procedure in the MSK structures of the pelvis and/or the spine
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Precision IO Group
Vertebral Compression Fracture
A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults.
- Trial name
- EXPAND (NCT07301749)
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 3 sites in France, Germany
- Volunteers
- 148 people
- Sponsor
- Amber Implants B.V.
Vertebral Compression Fracture
Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration
This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and…
- Trial name
- NCT07259811
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 2 sites in Germany
- Volunteers
- 10 people
- Sponsor
- Amber Implants B.V.
Healthy, Osteopenia
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-preFX (NCT06567054)
- Testing
- Measurements with the POROUS R3C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine, DXA-based Vertebral Fracture Assessment (VFA)
- Where
- 6 sites in Austria, Germany and 1 more
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Glucocorticoid-induced Osteoporosis
A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China
The main objective of this study is to evaluate the efficacy of Prolia® in improving bone mass density (BMD) of lumbar spine at month 12.
- Trial name
- NCT06588153
- Testing
- Prolia®
- Where
- 16 sites in China
- Volunteers
- 102 people
- Sponsor
- Amgen
Osteoporosis
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study.
- Trial name
- NCT07594639
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 305 people
- Sponsor
- AgNovos Healthcare, LLC
Fragility Fracture, Hip Fractures
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures.
- Conditions
- Fragility Fracture, Hip Fractures, Osteoporosis
- Trial name
- NCT04796350
- Testing
- AGN1 LOEP treatment
- Where
- 66 sites in Austria, Belgium and 9 more
- Volunteers
- 2,400 people
- Sponsor
- AgNovos Healthcare, LLC
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.
Osteopenia, Osteoporosis
Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults
The purpose of this study is to determine whether a modified formulation and daily intake schedule of SBD111 results in similar levels of probiotic microbes in the gut compared with the currently used formulation.
- Conditions
- Osteopenia, Osteoporosis, Menopause Related Conditions, Probiotic Intervention
- Trial name
- NCT07538167
- Testing
- SBD111(current formulation), SBD111 (new formulation)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Solarea Bio, Inc
Change in Bone Mineral Density, Bone Loss
LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
The primary objective of this study is to evaluate the impact of LF111 and drospirenone (DRSP) 3.5 mg chewable tablets on bone mineral density (BMD) at the lumbar spine after 12 months (13 medication cycles) of investigation in…
- Trial name
- NCT05303636
- Testing
- drospirenone 4 mg oral tablet or drospirenone 3.5 mg chewable tablet
- Where
- 37 sites in United States, Czechia and 1 more
- Volunteers
- 1,536 people, healthy volunteers welcome
- Sponsor
- Insud Pharma
Vertebral Compression Fracture
Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures
The overall purpose of conducting this study is to evaluate the safety and efficacy of V-Flex and V-Steady for augmentation of osteoporotic vertebral compression fractures and to verify that adding a cement softener into a PMMA…
- Trial name
- SOFTBONE (NCT05676320)
- Testing
- V-Flex, V-Steady
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 203 people
- Sponsor
- Inossia AB