Patients aged 50 years or older and indicated for pharmacologic treatment Osteoporosis* / drug therapy, Bone Density, Zoledronic acid
Conditions
Interventions
Zolasta: 4mg/5ml,Zoruxa: 5mg/100ml
Active Comparator Drug,Active Comparator Drug
4-mg Zoledronate,5-mg Zoledronate
Sponsors
Faculty of Medicine, Siriraj Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Population aged 50 years or older with one of the following 1. History of fragility fractures at the hip or spine resulting from low-energy trauma 2. Bone Mineral Density (BMD) measurement via Dual-energy X-ray Absorptiometry (DXA) scan at total femur, femoral neck or lumbar spine with a T-score less than or equal to -2.5 3. BMD measurement via DXA scan at total femur, femoral neck or lumbar spine with a T-score between -1 and -2.5, combined with a Thailand-specific FRAX assessment indicating a more than or equal to 3% probability of hip fracture within 10 years 4. BMD measurement via DXA scan at total hip or lumbar spine with a T-score between -1 and -2.5, accompanied by low-energy trauma fractures at proximal humerus, pelvis, or distal forearm
Exclusion criteria
Exclusion criteria: 1. Patients with secondary osteoporosis 2. Patients with prior anti-osteoporotic medication exposure within the past 12 months, including: Bisphosphonates, Estrogen hormones, Calcitonin, Selective Estrogen Receptor Modulators (SERM), Parathyroid hormone 3. Patients with documented bisphosphonate allergy 4. Patients with continuous oral glucocorticoid use at more than or equal to 2.5 mg prednisolone equivalent dose for more than 6 consecutive months 5. Patients with abnormal calcium levels: Serum calcium <9 or >12 mg/dL 6. Patients with severe vitamin D deficiency: Serum 25(OH)D <10 ng/mL 7. Patients with renal dysfunction: Estimated Glomerular Filtration Rate (eGFR) <45 mL/min (calculated by CKD-EPI) 8. Patients scheduled for dental surgical procedures within the next 12 months 9. Patients with atrial fibrillation 10. Patients with fracture history within the preceding 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density changed at lumbar spine 12 months percent change of raw number compared to baseline (from DXA scan) | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone mineral density changed at femoral neck and total femur 12 months percent change of raw number compared to baseline (from DXA scan),P1NP changed 3, 6, 12 months P1NP is a specific marker of bone formation from blood test. The percent change compared to baseline is associated with the effectiveness of zoledronate,B-CTX 3, 6, 12 months B-CTX is a specific marker of bone resorption from blood test. The percent change compared to baseline is associated with the effectiveness of zoledronate,adverse effect: common side effects include Flu-like symptom (e.g., Fever, myalgia, arthralgia, headache), Atrial fibriallation, osteonecrosis of the jaw, etc. 3, 6, 12 months We collected the number of events. ,fracture events 3, 6, 12 months number of events | — |
Countries
Thailand
Contacts
Public ContactAasis Unnanuntana
Faculty of Medicine, Siriraj Hospital, Mahidol University
Outcome results
None listed