NIPH Clinical Trials Search

The efficacy of abaloparatide in improving quality of life with reduction of lower back pain in new osteoporotic vertebral fractures

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Osteoporosis
Date of first enrollment	25/08/2025
Target sample size	120
Countries of recruitment
Study type	Interventional
Intervention(s)	After confirming that all eligibility criteria are met, random allocation to either the abaloparatide treatment group or the alendronate treatment group is performed. Eligibility verification and allocation may be performed on the same day as enrolment or on the following day if it is difficult to do so, but treatment with the study drug will be initiated within 14 days of the date of injury of the vertebral fracture under evaluation. The research treatment, including the administration of the research drug, is to be carried out for 12 weeks. Observation and investigation visits will be set at the start of the research treatment, 2 weeks, 4 weeks, 8 weeks and 12 weeks later.

Outcome(s)

Primary Outcome

Change in disease-specific quality of life assessment with the RDQ at 12 weeks

Secondary Outcome

1) Assessment of pain at the fracture site using the Numerical Rating Scale (NRS during the movement of getting up from the supine position and turning over from the supine position). 2) Comprehensive quality of life assessment using the EQ-5D. 3) Vertebral collapse ratio using simple X-ray images. 4) Vertebral kyphosis angle (Wedge angle, Kyphosis angle) using simple X-ray images. 5) Cleft formation on plain radiographs. 6) Bone density by DXA (frontal lumbar vertebrae, femoral neck). 7) Bone metabolism markers (P1NP, TRACP-5b) and 25-hydroxyvitamin D.

Key inclusion & exclusion criteria

Age minimum	>= 65age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) The patient has been diagnosed with osteoporosis according to the diagnostic criteria for primary osteoporosis. 2) A new vertebral fracture of only one vertebra has been identified in T11, T12 or L1-L5. 3) The new vertebral fracture in question has been determined by the physician to be a fragility fracture that occurred within the week prior to the date of obtaining consent. 4) Age at the time of occurrence of the causative vertebral fracture was 65 years or older. Gender and inpatient/outpatient status. 5) Pain due to the causative vertebral fracture and an NRS of 5 or more for either 'during the movement of getting up from the supine position' or 'during the movement of turning over from the supine position' at the time of obtaining consent. 6) Determined by a physician to have osteoporosis with a high risk of fracture.
Exclude criteria	1) Patients with contraindications to abaloparatide administration. Patients with hypercalcaemia, patients considered to be at high risk of developing osteosarcoma (patients with Paget's disease of bone, patients with unexplained high levels of alkaline phosphatase, patients who have received previous radiotherapy with possible bone effects), patients with primary malignant or metastatic bone tumours, patients with metabolic bone diseases other than osteoporosis, patients with a history of hypersensitivity to the drug. Patients with metabolic bone disease other than osteoporosis, patients with a history of hypersensitivity to this drug. 2) Patients with contraindications to alendronate administration. Patients with disorders that delay the passage of the oesophagus such as oesophageal stricture or achalasia (inability to relax the oesophagus), patients who are unable to remain upright or stand for more than 30 minutes, patients with a history of hypersensitivity to bisphosphonates, hypocalcaemia. 3) Patients who have used denosumab within the past year from the date consent was obtained. 4) Patients who have used teriparatide in the past from the date of consent. 5) Patients using bisphosphonates for more than 5 years, teriparatide, denosumab or romosozumab at the time the causative vertebral fracture occurred. 6) Patients with spinal implant insertion (including percutaneous vertebroplasty). 7) Patients with high-energy trauma. 8) Patients with impaired renal function (estimated Glomerular Filtration Rate (eGFR) less than 30 mL/min/1.73m2 based on the Glomerular Filtration Rate (GFR) estimation formula). 9) Patients with dementia who are unable to assess pain. 10) Patients who were unable to walk independently before the injury. 11) Patients with two or more new vertebral fractures at enrolment. 12) Patients undergoing treatment for malignancy (including patients with a history of osteosarcoma). 13) Patients taking oral steroids. 14) Patients with diabetes using insulin (type 1 diabetes and patients with type 2 diabetes using insulin). 15) Patients participating in clinical studies involving other interventions. 16) Other patients deemed unsuitable for this study by the principal investigator or sub-investigator.