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New drug combo aims to strengthen bones in elderly women

NCT ID NCT05058976

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a year of monthly injections of romosozumab, followed by an infusion of zoledronic acid, can improve bone density and prevent fractures in women aged 65 and older with osteoporosis who live in long-term care facilities. The goal is to find a treatment that works well for this vulnerable group. The study involves 184 participants and measures bone density at the hip and spine after 24 months.

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

184 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Mar 2027

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

65 years and older

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: Elderly women 65 years and older will be considered if: * They reside in an institution (nursing home or assisted living facility or senior care community); * They have a) osteoporosis by axial bone density (spine, hip or forearm BMD T-score≤ -2.5 SD), b) a previous adult fragility fracture of the spine or hip or c) would be treated based on FRAX and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of 10% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD. * Willing and able to complete the informed consent process or provide consent by proxy. Exclusion Criteria: * Those with subacute illnesses who are not expected to survive or who will be discharged in less than 2 years. * Those who have previously had an acute cardiovascular or cerebrovascular event within the preceding year. specifically, no recent history of coronary heart disease, heart failure, significant arrhythmia, stroke or Transient Ischemic Attack (TIA). * Recent cardiovascular disease (CVD) symptoms (significant chest pain, congestive heart failure, shortness of breath, or palpitations or cerebrovascular symptoms such as numbness or weakness in the face, arm, legs, difficulty talking, changes in vision, loss of balance, headache, feeling light-headed or dizzy). * Unstable angina. * Those who are currently on therapy (including a bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab) or have been on a bisphosphonate for greater than 1 year during the previous 2 years. * Those who are unable to take an intravenous bisphosphonate (zoledronic acid) due to renal insufficiency with eGFR \< 35 ml/min. * Vitamin D levels \<25 ng/mL. * Participants will be allowed to continue on medications known to affect bone and mineral metabolism (e.g., glucocorticoids, anticonvulsants) because their use is common in this population. * Those who have been treated in the past or present with osteoporosis agents, such as estrogen/progesterone or raloxifene will be allowed to participate and continue on these therapies if prescribed by their physician. * Patients will be allowed to wear hip pads if prescribed by their physician. * Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table) will be excluded.

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic osteoporosis Osteoporotic Fractures postmenopausal osteoporosis

As listed by the trial registrant

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

Contacts and locations

Locations

  • UPMC Senior Communities

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.