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Bone graft and drug combo may bolster hip fracture repair in osteoporosis patients

NCT ID NCT06135298

Disease control Sponsor: Aksaray University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tested whether adding a bone graft substitute (CERAMENT™) around the metal implant during hip fracture surgery, along with an osteoporosis drug (zoledronic acid), could improve bone density and fixation strength. Twenty patients with osteoporotic hip fractures were split into two groups: one received standard surgery, the other received the extra bone graft. Researchers measured bone density changes around the implant over 6 months using DEXA and CT scans.

What this could mean

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

Active substance
CERAMENT™ Bone Void Filler (calcium sulphate/hydroxyapatite) and zoledronic acid
What this could lead to
If successful, this approach could improve surgical fixation and reduce failure rates in osteoporotic hip fracture patients, potentially leading to better recovery and fewer reoperations.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply broadly. The treatment involves surgery and medication, which carry risks like infection or side effects from zoledronic acid.

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

20 people

The number who actually took part.

Started

Dec 2023

Finished

Jan 2026

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 to 90 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: * Being between 65-90 years of age at the time of fracture * Acute, unilateral proximal hip fracture (AO Foundation/Orthopaedic Trauma Association \[AO/OTA\]: A1 and A2) caused by low energy trauma * Physical condition eligible for surgery with proximal femoral nail * Having low mortality and high fracture risk according to Fracture and Mortality Risk Evaluation Index (FAME) classification * Patient with communicative ability to understand the procedure and participate in the study and the follow-up program, consented to be included in the study and signed the consent form Exclusion Criteria: * Previous hip or pelvis fracture on the same side * Concurrent corticosteroid treatment * Concurrent medical osteoporosis treatment * Irreversible coagulopathy or bleeding disorder. o Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators will follow routine practices for perioperative discontinuation and re-initiation of anti-coagulants. * Concurrent dialysis or elevated creatinine * Presence of hypo- or hyper calcaemia * History or active treatment due to malignancy involving the pelvis/hip area, including ongoing or completed radiotherapy * Fractures involving acetabulum * Active systemic infection or local skin infection at the incision site * Known hyperthyroidism or thyroid adenoma, * History of serious reaction to iodine-based radio contrast agents * Patient without communicative ability to understand the procedure and participate in the study and the follow-up program, did not consent to be included in the study and/or did not sign the consent form

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic hip fracture

As listed by the trial registrant

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

Bone density, low Hip fractures Osteoporotic fracture of femur Trochanteric fracture of femur

Contacts and locations

Locations

  • Aksaray University Training and Research Hospital

    Aksaray, Aksaray, 68200, Turkey (Türkiye)

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