NCT07281586RecruitingPhase 4
Step-down Therapy After Long-term Osteoporosis Treatment
Step-down Therapy After Long-term Osteoporosis Treatment: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
Maintaining bone mineral density (BMD) after discontinuing denosumab (Prolia) is a major clinical challenge, as rapid bone loss commonly occurs when treatment is stopped, especially after more than three years of use. Standard sequential therapy with bisphosphonates such as zoledronic acid (Aclasta) often fails to fully prevent BMD decline, and most bone loss occurs within the first year, making effective suppression of the rebound effect essential. This study investigates whether a de-escalation strategy-using half-dose denosumab (30 mg every six months) combined with sequential zoledronic acid-can better preserve lumbar spine BMD after long-term denosumab therapy. Eligible participants include postmenopausal women and men ≥50 years old with osteoporosis or osteopenia-related fractures who have received ≥3 years of denosumab. The open-label trial applies stratified randomization based on denosumab duration (\<4 years vs. ≥4 years), assigning 22 participants to each group. Control group: standard therapy with one zoledronic acid infusion at the end of denosumab's effect and a second infusion one year later. Intervention group: half-dose denosumab plus zoledronic acid at study entry, a second half-dose denosumab injection at six months, and a second zoledronic acid infusion at twelve months. The study aims to determine whether this combined tapering-plus-bisphosphonate approach more effectively prevents lumbar spine BMD loss compared with conventional sequential therapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT07281586
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 44
- From 1 Jan 2026 to the primary completion date, 31 Dec 2028
- 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.
Lab values
- Secondary osteoporosis Metabolic bone diseases Active or prior malignancy Ongoing systemic glucocorticoid therapy Current use of hormone replacement therapy Use of any medications that affect bone metabolism Estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73 m² Known hypersensitivity to zoledronic acid Hypocalcemia Any other contraindications to zoledronic acid use
Who the study is looking for
- Postmenopausal women aged ≥50 and ≤85 years with osteoporosis- or osteopenia-related fractures who have received denosumab (Prolia) continuously for at least 3 years, with no dosing interval exceeding 9 months; and men aged ≥50 and ≤85 years with osteoporosis- or osteopenia-related fractures who have received continuous denosumab (Prolia) therapy for at least 3 years, with dosing intervals not exceeding 9 months.
Age in the registry: 50 years to 85 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 |
|---|---|---|---|
| National Taiwan University Hospital Yunlin Branch Coordinator of this site? Confirm its status | Douliu | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.