The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age50-85
SponsorNational Taiwan University Hospital
About this trial
This study is a prospective, multicenter, open-label, randomized non-inferiority trial comparing intravenous ibandronate and zoledronic acid as sequential therapy after denosumab discontinuation in postmenopausal women with osteoporosis. This trial primarily targets patients with short-term denosumab exposure (less than three years) and is conducted as a preliminary investigation. The findings are expected to provide foundational evidence to inform the design of future studies assessing sequential therapies following longer-term denosumab treatment.
Eligibility criteria
Qualifiers
Postmenopausal women aged 50 to 85 years.
BMD T-score ≤ -1.5 and > -3.0 at the lumbar spine or total hip.
Regular treatment with denosumab administered every 6 months for at least 1 year and less than 3 years (3 to 5 doses).
Physically and mentally capable of understanding and complying with the study protocol and follow-up.
Disqualifiers
History of fragility or osteoporotic fracture within the past 12 months.
Current or prior treatment within the past 12 months with osteoporosis medications other than denosumab, including Romosozumab, Teriparatide, Alendronate, Ibandronate, Zoledronic acid, Risedronate and Raloxifene.
Allergy to bisphosphonates.
Secondary osteoporosis.
Trial design
Treatments tested in this trial
- Ibandronate IV
- Zoledronic acid IV
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
National Taiwan University Hospital
Lead sponsor
National Taiwan University
Collaborator
Source ClinicalTrials.gov