Clinical trials: Osteoporosis Fracture
Osteoporotic Fracture
Phase I Clinical Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of LYN101
This is a Phase 1, two-part, first-in-human, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of LYN101 in healthy subjects (part A)…
- Trial name
- NCT07178327
- Testing
- LYN101
- Where
- 2 sites in China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Shanghai TTM-Bio Technology Co., Ltd
Osteoporosis, Osteopenia
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects…
- Trial name
- NCT00330460
- Testing
- Alendronate, Denosumab
- Volunteers
- 1,189 people
- Sponsor
- Amgen
Osteopenia, Osteoporosis
FREE Study - Fracture Reduction Evaluation
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.
- Conditions
- Osteopenia, Osteoporosis, Multiple Myeloma, Bone Neoplasms
- Trial name
- NCT00211211
- Testing
- Balloon Kyphoplasty
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Spine LLC
Male Osteoporosis
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.
- Trial name
- NCT00439647
- Testing
- Zoledronic acid 5 mg iv
- Where
- 128 sites in Argentina, Australia and 21 more
- Volunteers
- 1,199 people
- Sponsor
- Novartis Pharmaceuticals
Osteoporosis
Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
- Trial name
- YY_PK_2011 (NCT01526278)
- Testing
- Maxmarvil®
- Where
- South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Yuyu Pharma, Inc.
Postmenopausal Osteoporosis
Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk
A randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial to compare the efficacy and safety of QL1206 and placebo in postmenopausal women with osteoporosis at high risk of fracture
- Trial name
- NCT04128163
- Testing
- QL1206
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Fall, Fall Patients
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of…
- Conditions
- Fall, Fall Patients, Osteoporosis
- Trial name
- FAIR (NCT05155761)
- Testing
- FeetMe® Monitor
- Where
- France
- Volunteers
- 250 people
- Sponsor
- FeetMe
Osteoporosis
GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study.
- Trial name
- NCT05966974
- Where
- Belgium
- Volunteers
- 44 people
- Sponsor
- AgNovos Healthcare, LLC
Spinal Fractures
A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis
Doctors are studying an investigational treatment to be used during the vertebroplasty procedure when treating vertebral compression fractures (spine fractures) that may help to reduce pain and restore mobility.
- Trial name
- NCT00290862
- Testing
- Percutaneous Vertebral Augmentation of compression fractures
- Where
- 18 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- Orthovita d/b/a Stryker
Osteoporosis
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study.
- Trial name
- NCT05202678
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- AgNovos Healthcare, LLC
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
Osteoporosis
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
- Trial name
- BILANZ (NCT01512446)
- Testing
- Alendronate
- Where
- Germany
- Volunteers
- 436 people
- Sponsor
- Evangelisches Krankenhaus Lutherhaus gGmbH
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.
Hip Fractures, Osteoporosis, Postmenopausal
STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture
To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.
- Trial name
- NCT03268356
- Testing
- AGN1 Femoral Local Osteo-Enhancement Procedure Kit
- Where
- Hong Kong
- Volunteers
- 13 people
- Sponsor
- AgNovos Healthcare, LLC
Osteoporosis
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial.
- Trial name
- NCT00145327
- Testing
- Zoledronic Acid
- Where
- 31 sites in United States, Germany
- Volunteers
- 2,456 people
- Sponsor
- Novartis
Painful Osteoporotic Vertebral Compression Fractures (VCF)
The PRIORi-T Trial--Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation
The objective of this post market clinical investigation is to evaluate the clinical effectiveness of a minimally invasive vertebral augmentation procedure, Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to…
- Trial name
- PRIORi-T (NCT01480167)
- Testing
- Vertebral Augmentation (STABILIT), Non-operative Management
- Where
- 6 sites in United States
- Sponsor
- DFINE Inc.
Spinal Fractures, Vertebral Compression Fractures
Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus…
- Conditions
- Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Osteoporosis
- Trial name
- SAKOS (NCT02461810)
- Testing
- Vertebral fracture surgery SpineJack®, Balloon Kyphoplasty
- Where
- 13 sites in France, Germany and 3 more
- Volunteers
- 152 people
- Sponsor
- Vexim SA
Osteoporosis, Postmenopausal Osteoporosis
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.
- Trial name
- ACTIVE (NCT01343004)
- Testing
- BA058 80 mcg, teriparatide
- Where
- 28 sites in United States, Argentina and 8 more
- Volunteers
- 2,463 people
- Sponsor
- Radius Health, Inc.
Osteoporosis, Postmenopausal
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be…
- Trial name
- TOP (NCT01381588)
- Testing
- Fracture evaluation
- Where
- South Korea
- Volunteers
- 1,136 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.