Status:
COMPLETED
A Clinical Trial to Evaluate Efficacy of Once or Twice ZOledronic Acid After Different Duration of denOsumMab Administration in Postmenopausal Women With Osteoporosis (ZOOM Study)
Lead Sponsor:
Yonsei University
Conditions:
Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
Brief Summary
Denosumab(Dmab) is a monoclonal antibody that inhibits the receptor-activator of nuclear factor kappa-B ligand. It improves bone density and reduces fractures by inhibiting osteoclast recruitment and ...
Detailed Description
Background Dmab is an osteoporosis treatment that improves bone density and lowers the risk of fractures. However, in a recent study, it is known that cases in which bone density decreases and multipl...
Eligibility Criteria
Inclusion
- Postmenopausal women (defined as no menstruation for more than 48 weeks prior to screening and no other pathological or physiological causes. If in doubt, a serum follicle-stimulating hormone (FSH) test may be performed at screening)
- Patients diagnosed with osteoporosis, osteoporotic fractures, received at least two doses of denosumab, and who have osteopenia in follow-up DXA
Exclusion
- Secondary osteoporosis (Systemic glucocorticoid use, aromatase inhibitor, thyrotoxicosis, hypeparathyroidism, etc)
- Active cancer treatment
- Inflammatory bowel disease
- History of medication related osteonecrosis of jaw(MRONJ)
- low-energy fracture within the last 12months
- Estimated glomerular filtration rate (eGFR) \< 35 mL/min
- Hepatic dysfunction (aspartate transaminase (AST)/alanine transferase (ALT) \> 3 x upper normal limit)
- Contraindication for zoledronic acid according to the SPC
- Allergic to zoledronic acid
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05361408
Start Date
February 11 2022
End Date
February 13 2024
Last Update
March 7 2025
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea