NCT05361408CompletedPhase 4
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)
A Single Center, Open-label, Parallel, Phase IV Clinical Trial to Evaluate Efficacy of Once or Twice ZOledronic Acid After Different Duration of denOsumMab Administration in Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
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 differentiation. Although the FREEDOM trial showed Dmab increase bone mineral density for ten years, the effect was reversible. When Dmab is discontinued, the rebound phenomenon, the bone mineral density returns to the pre-treatment value, and multiple vertebral fractures may occur. Recently, a guideline to administer bisphosphonates sequentially when Dmab is discontinued has been published. In several studies, Zoledronic acid prevented bone loss after denosumab discontinuation with a single administration in Dmab short-term(less than 2.5years) users, but in Dmab long-term(more than 2.5years) users, zoledronic acid did not fully prevent loss of BMD. Our study tried to evaluate that ZOL administration twice for six months apart in long-term Dmab users is not inferior to a single administration of ZOL in Dmab short-term users.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 29 Apr 2022
- Start date
- 11 Feb 2022
- Primary completion date
- 13 Feb 2024
- Lead sponsor
- Yonsei University
- Diseases
- Osteoporosis
- NCT number
- NCT05361408
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 114
- From 11 Feb 2022 to the primary completion date, 13 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Secondary osteoporosis (Systemic glucocorticoid use, aromatase inhibitor, thyrotoxicosis, hypeparathyroidism, etc)
Other illness
- Active cancer treatment
- Inflammatory bowel disease
- History of medication related osteonecrosis of jaw(MRONJ)
- Allergic to zoledronic acid
Lab values
- Estimated glomerular filtration rate (eGFR) \< 35 mL/min
- Hepatic dysfunction (aspartate transaminase (AST)/alanine transferase (ALT) \> 3 x upper normal limit)
Other
- low-energy fracture within the last 12months
- Contraindication for zoledronic acid according to the SPC
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University Health System, Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.