Denosumab and vertebral kyphoplasty for osteoporotic vertebral compression fractures

Denosumab effect on bone mineral density and function at 1 year after vertebral kyphoplasty for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100051404

Enrollment

Unknown

Registered

2021-09-23

Start date

2021-09-23

Completion date

Unknown

Last updated

2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporotic vertebral compression fractures

Interventions

Experimental group:Denosumab

Control group:Placebo

Eligibility

Sex/Gender

All

Age

40 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 40 to 90 years; 2.X-ray diagnosis of 1-2 vertebral compression fractures; 3.DEXA test BMD T value was less than -1; 4.A history of fractures lasting less than 6 weeks; 5.Magnetic resonance imaging (MRI) could be performed, MRI showed bone marrow edema of injured segment; 6.There is lower back pain, local spinous tenderness.

Exclusion criteria

Exclusion criteria: 1.Patients with posterior vertebral wall fracture; 2.Patients with intervertebral fissure; 3.Infection; 4.Malignancy; 5.Neurological dysfunction; 6.Previous use of anti-osteoporosis drugs; 7.Prior back surgery, and other established contraindications for elective surgery.

Design outcomes

Primary

Measure	Time frame
Osteocalcin in the N terminal molecular fragment;N-terminal propeptide P1NP of procollagen type 1;C-terminal crosslinking type 1 collagen terminal peptide CTx;Serum total calcium;Parathyroid hormone;Total phosphorus;Total alkaline phosphatase;Albumin;Dual- energy X-ray examination of lumbar spine bone mineral density;Hip bone density;Computed tomography scan for bone fracture segment;Magnetic resonance imaging was used to detect bone marrow edema and adjacent intervertebral discs below;Fracture segments were recorded;Anti-osteoporosis medications;Symptom duration;Vertebral height loss;Genant grade;Nonsteroidal pain medication use;Cobb angle;Numeric Pain Scale;Visual simulation of pain questionnaire;European Five-dimension Health Scale Quality of Life Questionnaire;	—

Measure

Time frame

Osteocalcin in the N terminal molecular fragment;N-terminal propeptide P1NP of procollagen type 1;C-terminal crosslinking type 1 collagen terminal peptide CTx;Serum total calcium;Parathyroid hormone;Total phosphorus;Total alkaline phosphatase;Albumin;Dual- energy X-ray examination of lumbar spine bone mineral density;Hip bone density;Computed tomography scan for bone fracture segment;Magnetic resonance imaging was used to detect bone marrow edema and adjacent intervertebral discs below;Fracture segments were recorded;Anti-osteoporosis medications;Symptom duration;Vertebral height loss;Genant grade;Nonsteroidal pain medication use;Cobb angle;Numeric Pain Scale;Visual simulation of pain questionnaire;European Five-dimension Health Scale Quality of Life Questionnaire;

—

Secondary

Measure	Time frame
Roland-Morris disability function questionnaire;Osteoporosis QUALEFO-31 questionnaire;	—

Countries

China

Contacts

Public ContactWang Hongyu

The First Affiliated Hospital, Southern University of Science and Technology (Shenzhen People's Hospital)

wanghongyu790039663@126.com+86 18241651300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026