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New study tests best way to cycle osteoporosis drugs for stronger bones

NCT ID NCT06938152

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two treatment schedules for postmenopausal women with severe osteoporosis. One group gets romosozumab for 12 months then denosumab for 12 months. The other group cycles between the two drugs every 6 months for 2 years. Researchers will measure bone density and pain to see which schedule works better.

What this could mean

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

Active substance
Romosozumab and Denosumab (drugs given in sequence or cycles)
What this could lead to
If successful, this could identify a more effective dosing schedule for these osteoporosis drugs, potentially leading to better bone density gains and fewer fractures.
What could go wrong
This is a small, early-phase 4 trial with only 70 participants, so results may not apply to all patients. The drugs have known risks like jaw problems or unusual thigh fractures, and cycling may not prove better than standard treatment.

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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

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 90 years

Sex

Female participants only

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 aged 50-90 years * 2\. BMD T-score ≤ -3.0 at any lumbar vertebra * 3\. Physically and mentally capable of understanding and complying with the study protocol and follow-up * 4\. Signed informed consent Exclusion Criteria: * 1\. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene * 2\. Allergy to Romosozumab or Denosumab * 3\. Secondary osteoporosis * 4\. Autoimmune disease * 5\. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients) * 6\. Hypercalcemia or hypocalcemia * 7\. Metabolic bone diseases * 8\. Primary or metastatic bone tumors * 9\. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years) * 10\. Planned dental procedures (e.g., extractions, implants) within the next year * 11\. History of stent placement, myocardial infarction, stroke, or coronary artery disease * 12\. Renal disease (Creatinine \> 1.5 mg/dL) or dialysis patients * 13\. Smoking more than one pack per day (except for those who have quit for over ten years)

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Conditions

The condition(s) this trial relates to.

osteoporosis postmenopausal osteoporosis

As listed by the trial registrant

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

Osteoporosis Osteoporosis postmenopausal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

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