lumbar degenerative disease lumbar degenerative disease
Conditions
Interventions
Preoperative avaloparatide group 80 micrograms of avaloparatide once daily by subcutaneous injection.
Patients not receiving avaloparatide preoperatively VD3 eldecalcitol at the prescribed dosage
Sponsors
Haro Hirotaka
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Based on the results reviewed at the implementing institution, the principal investigator will determine that the following (1) through (3) are met at the time of enrollment. (1) Postmenopausal women who are 50 years of age or older at the time consent is obtained (2)Patients who are eligible for spinal fusion surgery with one intervertebral PLIF (TLIF) at L3-5 due to grade 1 or 2 lumbar degenerative spondylolisthesis or degenerative scoliosis (3)Osteoporotic patients at high risk of fracture who have any of the following 1)YAM value of bone mineral density in whole femur DEXA at the time of enrollment is less than or equal to 70% (T-score -2.5 SD or less)*. 2) Whole femur DEXA at enrollment with a YAM value of bone density greater than 70% and less than 80% (T-score -2.5SD to less than -1.8SD) and at least one fragile existing vertebral fracture or a history of fragile proximal femur fracture (excluding L3-L5)*. *When using femoral bone mineral density as a selection criterion, the lower BMD value on either side should be used. (Based on the diagnostic criteria for primary osteoporosis of the Japanese Society of Bone Metabolism (2012 revised version), femur should be measured bilaterally and the lower YAM value should be used. The one with less OA change should be adopted first.)
Exclusion criteria
Exclusion criteria: (1) Patients who are not eligible for lumbosacral posterior intervertebral fusion (2) Patients who are unable to give consent to participate in the study or complete the questionnaire due to physical or mental condition (3)Patients with pre-existing fracture in L3-L5 vertebrae eligible for surgery (4)Patients with a history of use of the following drugs that affect bone metabolism 1)Patients who have received any of the following osteogenesis-promoting agents prior to the date of enrollment Patients who have used at least once abaloparatide, other PTH products, or anti-sclerostin antibodies 2) Patients who received any of the following bone resorption inhibitors prior to the date of registration Patients who used anti-RANKL antibody at least once, or used bisphosphonates for more than 5 consecutive years (5) Patients with a history of malignancy, however, patients who have received appropriate treatment by the date of enrollment and have had no recurrence by the date of enrollment may be enrolled. (6)Patients with a history of osteosarcoma (7) Patients with the following conditions Hyperparathyroidism Hypercalcemia Hypercalciuria Hypophosphatemia History of treatment for urinary tract stone disease (8) Patients with contraindications to the study drug to be used [see attached document]. (9)Patients who could not give consent to participate in this study (10)Patients with psychiatric disorders or dementia (11)Patients deemed inappropriate by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vertebral bone strength during vertebral body fusion (torque pressure during tapping performed at the time of PS puncture) | — |
Contacts
Public ContactTetsuro Ohba
University Of Yamanashi Hospital
Outcome results
None listed