The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ibandronate IV
DrugIbandronate 3mg/3months for 12 months
Zoledronic acid IV
DrugZoledronic acid 5mg/1year for 12 months
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Ibandronate groupExperimental treatment 1 intervention
Group B: Zoledronic acid groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage change in bone mineral density (BMD)
Change in BMD at the lumbar spine, femoral neck, and total hip measured by dual-energy X-ray absorptiometry (DXA) from baseline to 24 months. Baseline is defined as the time point 6 months after the last dose of denosumab, immediately prior to initiation of sequential therapy. BMD measurements will be performed at 6, 12, 18, and 24 months after treatment initiation.
Time frame
Baseline to 24 months after treatment initiation.Secondary outcomes
1
Change in bone turnover makers (BTM) level
Changes in serum bone turnover markers, including procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide of type I collagen (CTX), will be evaluated to assess bone metabolic activity following denosumab discontinuation and sequential therapy. Measurements will be obtained at baseline and at 3, 6, 9, 12, 18, and 24 months after treatment initiation.
Time frame
Baseline to 24 months2
Change in visual Analogue Scale (VAS) score
The Visual Analogue Scale (VAS) for pain will be used to assess participants' self-reported pain intensity. The VAS score ranges from 0 to 10, higher scores indicate worse pain intensity, and lower scores indicate less pain. Pain intensity of the lower back and lower extremities will be evaluated at baseline and every 6 months during follow-up.
Time frame
Baseline to 24 months3
Incidence of osteoporotic fractures
The occurrence and anatomical sites of osteoporotic fractures will be recorded throughout the study period.
Time frame
During the intervention period, up to 24 months.4
Incidence of adverse events (AEs) and serious adverse events (SAEs)
All AEs and SAEs will be recorded and evaluated throughout the study period to assess the safety of sequential therapy.
Time frame
During the intervention period, up to 24 months.Sponsors and contacts
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National Taiwan University Hospital
Lead sponsor
National Taiwan University
Collaborator
Source ClinicalTrials.gov