NCT03868033CompletedPhase 4
Denosumab Sequential Therapy
Department of Orthopedics, National Taiwan University Hospital
Source: ClinicalTrials.gov · Last updated 23 Apr 2024
Brief summary (registry, in English)
Denosumab is a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications, even up to ten years, it's effect is reversible. After holding the drug, circulating denosumab levels fall rapidly, and bone resorption reaching twice baseline levels for about 6 months. How to prevent bone loss after denosumab therapy is an important issue, especially when considering the compliance, persistence, or other comorbidities of the patient. We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 6 Mar 2019
- Start date
- 12 Apr 2019
- Primary completion date
- 1 Jul 2023
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT03868033
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 101
- From 12 Apr 2019 to the primary completion date, 1 Jul 2023
- 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
- Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism
Other illness
- Malignancy
- Metabolic bone diseases
Age
- Patients older than 80 years old
Other
- Patientshadeverusedantiosteoporosismedications other than Dmab
- Estimated glomerular filtration rate \<35 ml/min.
- Secondary osteoporosis
- Contraindications to ZOL
- Hypocalcemia
Who the study is looking for
- Postmenopausal women
- Men \>50-year-old
- After Denosumab treatment ≥ 2 years due to osteoporosis
Age in the registry: 50 years to 80 years · Sex: All · 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 |
|---|---|---|---|
| Department of Orthopedics, National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
Related publications
- The third-year results of denosumab sequential therapy trial: An extension of a randomized clinical trial.J Formos Med Assoc · 2026 · PMID 42786015
This page is information, not medical advice. Discuss any trial with your doctor.