Step-down Therapy After Long-term Osteoporosis Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

zoledronate: In the control arm, participants will receive zoledronate at trial entry, with a second dose administered at the start of the second year

zoledronate: In the intervention arm, participants will receive zoledronate at trial entry, with a second dose administered at the start of the second year.

Denosumab De-escalation: In the intervention arm, participants will receive a half-dose of denosumab at trial entry, followed by a second half-dose 6 months later during the first year.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Lumbar Spine BMD Over 2 Years — 2 Years
  Change in Lumbar Spine BMD Over 2 Years

Trial sites (1)

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