Clinical trials: SPINAL Fracture
Osteoporosis
Study of FORTEO Use in Subjects in the Community Setting
The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of FORTEO in a larger, more diverse "real world" population than studied in clinical trials
- Trial name
- DANCE (NCT01078805)
- Testing
- FORTEO
- Where
- United States
- Volunteers
- 4,167 people
- Sponsor
- Eli Lilly and Company
Spinal Fractures
PASS MIS® Post-market Clinical Follow-up
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
- Trial name
- NCT02931266
- Testing
- PASS MIS®
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Medicrea International
Spinal Cord Neoplasms, Spinal Fractures
The Development of a Vertebra Localizing Aid Medical Device
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made.
- Trial name
- NCT02603874
- Testing
- Target Tape
- Volunteers
- 100 people
- Sponsor
- Target Tape
Back Pain
Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain
Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture. Secondary objectives were: to assess the safety and tolerability of REGN475/SAR164877 in patients…
- Trial name
- NCT01001715
- Testing
- REGN475/SAR164877
- Where
- 11 sites in United States
- Volunteers
- 41 people
- Sponsor
- Regeneron Pharmaceuticals
Osteoporosis
Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
This study aims to evaluate the safety and analgesic effect (efficacy) of Gastrolith powder (GASP) on skeletal pain caused by osteoporotic vertebral compression fractures (OVCF) versus placebo, primarily as assessed by the…
- Trial name
- NCT01482858
- Testing
- Gastrolith
- Where
- 5 sites in Israel
- Sponsor
- Amorphical Ltd.
Cancer, Hematologic Malignancies
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology
- Trial name
- NCT01345019
- Testing
- Denosumab, Zoledronic acid, Denosumab (for the open-label treatment phase)
- Where
- 309 sites in United States, Australia and 27 more
- Volunteers
- 1,718 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
- Trial name
- VERO (NCT01709110)
- Testing
- Teriparatide, Risedronate, Calcium
- Where
- 103 sites in United States, Argentina and 13 more
- Volunteers
- 1,366 people
- Sponsor
- Eli Lilly and Company
Bone Metastases
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple…
- Trial name
- NCT00330759
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 1,779 people
- Sponsor
- Amgen
Vertebral Body Fractures
Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting
This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine.
- Trial name
- NCT01847898
- Testing
- Vertebral Body Stenting (VBS), Balloon Kyphoplasty
- Where
- 5 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- Synthes GmbH
Osteoporosis, Postmenopausal
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
The purpose of this trial is to study: Effects of arzoxifene on bone fractures and bone mass. Effects of arzoxifene on getting breast cancer.
- Trial name
- NCT00088010
- Testing
- Arzoxifene
- Where
- United States
- Volunteers
- 9,369 people
- Sponsor
- Eli Lilly and Company
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Spinal Fractures
Study to Investigate the Long Term Survivorship of Coflex
Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.
- Trial name
- NCT02918669
- Testing
- CT Scan
- Volunteers
- 12 people
- Sponsor
- Paradigm Spine
Failed Lumbar Fusion
Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion
Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon.
- Trial name
- NCT02328287
- Testing
- ALLOB®
- Where
- 3 sites in Belgium
- Volunteers
- 6 people
- Sponsor
- Bone Therapeutics S.A
Kyphosis, Spinal Fractures
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
- Trial name
- LOADPRO (NCT02768675)
- Testing
- LOADPRO
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Intellirod Spine
Vertebral Fracture, Compression Fracture
Spine Bone Cements Outcomes - Post Market Follow-up
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all…
- Conditions
- Vertebral Fracture, Compression Fracture, Osteoporotic Fractures
- Trial name
- NCT06367582
- Testing
- Vertebroplasty (VP), Kyphoplasty (KP), Pedicular Screw Augmentation (PSA)
- Where
- 12 sites in France, Portugal and 2 more
- Volunteers
- 500 people
- Sponsor
- Teknimed
Cancer, Spinal Fractures
CAFE Study - Cancer Patient Fracture Evaluation
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients…
- Trial name
- CAFE (NCT00211237)
- Testing
- Balloon Kyphoplasty, Non Surgical Management
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 134 people
- Sponsor
- Medtronic Spine LLC
Trauma, Tumor
Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System
- Conditions
- Trauma, Tumor, Pseudarthrosis, Scoliosis
- Trial name
- VueLock (NCT00726128)
- Testing
- VueLock™ Anterior Cervical Plate
- Where
- 4 sites in United States
- Volunteers
- 371 people
- Sponsor
- Zimmer Biomet
Multiple Myeloma, Compression Fracture of Vertebral Column
Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma
The objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.
- Trial name
- MM (NCT01410929)
- Testing
- Kyphoplasty/Vertebral Augmentation (Device-StabiliT)
- Sponsor
- DFINE Inc.
Pathologic Fracture of the Vertebra Due to Osteoporosis
Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients
The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
- Trial name
- NCT00933036
- Testing
- Crosstrees Pod system for PVA
- Where
- 9 sites in United States
- Volunteers
- 135 people
- Sponsor
- Crosstrees Medical Inc.
Osteoporosis
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
- Trial name
- DIRECT (NCT00680953)
- Testing
- Denosumab, Alendronate sodium hydrate
- Where
- 4 sites in Japan
- Volunteers
- 1,262 people
- Sponsor
- Daiichi Sankyo Co., Ltd.