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Bone drug switch: can alendronate and zoledronate keep bones strong after denosumab?

NCT ID NCT05091099

Disease control Sponsor: National Taiwan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the best way to prevent bone loss after stopping denosumab, a common osteoporosis treatment. Researchers tested giving alendronate first, then zoledronate, versus zoledronate alone in 44 postmenopausal women and men over 50. The goal was to see which approach better maintains bone density and reduces fracture risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
alendronate and zoledronate (bisphosphonate drugs)
What this could lead to
If it works, this could provide a clear treatment plan to maintain bone strength after stopping denosumab, reducing fracture risk.
What could go wrong
This is a small, single-center study with only 44 participants, so results may not apply to everyone. The drugs may not fully prevent bone loss.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

44 people

The number who actually took part.

Started

Jan 2022

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Postmenopausal women or men over 50 years old 2. Continuous Denosumab treatment for at least three years (up to six doses). Exclusion Criteria: 1. Secondary osteoporosis 2. Metabolic bone diseases 3. Active or prior malignancy 4. Ongoing systemic glucocorticoid therapy 5. Current use of hormone replacement therapy 6. Current use of any medication known to affect bone metabolism 7. Prior use of any osteoporosis medication other than denosumab 8. Estimated glomerular filtration rate (eGFR) \< 40 mL/min 9. Known hypersensitivity to zoledronic acid 10. Hypocalcemia 11. Any other contraindication to zoledronic acid 12. Age \> 85 years 13. Esophageal abnormalities that delay esophageal emptying (e.g., esophageal stricture, achalasia) 14. Inability to stand or sit upright for at least 30 minutes

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Conditions

The condition(s) this trial relates to.

osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis

Contacts and locations

Locations

  • National Taiwan University Hospital, Yunlin branch

    Douliu, Yunlin County, 640, Taiwan

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