WithdrawnPhase 2/3

Denosumab and Screw Fixation for Osteoporotic Compression Fracture

Stopped: no partcipants enrolled

China0Started 2021-09-14

Plain-language summary

Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:• Must be age between 40 and 90 years old * X-ray diagnosis of 1-2 vertebral compression fractures * Dual energy X ray test bone mineral density T value less than -1 * fracture history lasted within 6 weeks * MRI showed bone marrow edema of injured segment * lower back pain, local spines tenderness Exclusion Criteria: * • Must be able to have no posterior vertebral wall fracture * Must be able to have no patients with intervertebral fissure * Must be able to have no infection * Must be able to have no malignancy * Must be able to have no neurological dysfunction * Must be able to have no previous use of anti-osteoporosis drugs within 6 weeks * Must be able to have no inability to perform magnetic resonance imaging * Must be able to have no prior back surgery * Must be able to have no other established contraindications for elective surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

age

Timeframe: up to 12 months

sex

Timeframe: up to 12 months

height

Timeframe: up to 12 months

weight

Timeframe: up to 12 months

BMI

Timeframe: up to 12 months

osteocalcin

Timeframe: up to 12 months

Procollagen type 1 n-terminal propeptide P1NP

Timeframe: up to 12 months

C-terminal cross-linked type 1 collagen terminal peptide CTX

Timeframe: up to 12 months

Trial details

NCT IDNCT05065164

SponsorShenzhen People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-20

View on ClinicalTrials.gov More Denosumab Allergy trials

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

age

Timeframe: up to 12 months

sex

Timeframe: up to 12 months

height

Timeframe: up to 12 months

weight

Timeframe: up to 12 months

BMI

Timeframe: up to 12 months

osteocalcin

Timeframe: up to 12 months

Procollagen type 1 n-terminal propeptide P1NP

Timeframe: up to 12 months

C-terminal cross-linked type 1 collagen terminal peptide CTX

Timeframe: up to 12 months