Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion

  • STATUS
    Recruiting
  • End date
    Oct 22, 2023
  • participants needed
    116
  • sponsor
    Shanghai Changzheng Hospital
Updated on 22 March 2022
calcium
vitamin d
x-rays
denosumab
osteoporosis
bone mineral density
RANKL
dual-energy x-ray absorptiometry
x-ray absorptiometry

Summary

Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a concomitant increase in prevalence of osteoporosis which is a detrimental factor for Lumbar fusion and instrumentation. Osteoporosis-related bone fragility is a primary reason for spinal fusion failure, implant fixation failure, and vertebral compression fractures above or below the fusion sites.

Denosumab is a human monoclonal antibody against RANKL, it inhibits osteoclast mediated bone destruction and has been found to be effective in treating osteoporosis, including reducing bone turnover markers, increasing bone mineral density (BMD), and reducing fractures. But few studies focus on the effects of Denosumab on lumbar fusion. In this study, we include osteoporotic patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. The patients were randomized to either treatment of Denosumab or no treatment. All these patients are followed at 3, 6, 9, 12 months postoperation. During these periods, we detect bone metabolism and bone fusion of these patients. Finally, we would report whether Denosumab can improve bone metabolism and promote bone fusion or not.

Details
Condition Osteoporosis, Fusion of Spine, Lumbar Region
Treatment Calcium and vitamin D, Denosumab 60 mg/ml Injectable Solution [Prolia]
Clinical Study IdentifierNCT05203588
SponsorShanghai Changzheng Hospital
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of degenerative lumbar diseases with symptoms of low-back pain and/or leg pain for at least 3 months, which was not be adequately controlled by nonoperative treatments
Diagnosis of osteoporosis, defined as a bone mineral density (BMD) at lumbar or femoral neck with 2.5 standard deviations or more below the mean peak bone mass (T scores <-2.5 SD) measured by dual-energy X-ray absorptiometry (DXA)
Patients will be underwent single-level or two-level lumbar interbody fusion

Exclusion Criteria

Paget disease of bone
Low laboratory tests for calcium
Previous radiation treatment or fusion surgery to lumbar spine
Bone tumors
Bone infection
Acute vertebral fractures
Severe spinal deformities such as degenerative scoliosis
Other metabolic bone disease
History of a anti-osteoporosis medication
Combined with severe morbidities
Uncorrected bleeding diatheses
Application of steroids
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note