Desomumab and lumbar spinal stenosis

Evaluation of bone mineral density and function at 1 year after lumbar spinal stenosis and fusion with desomumab: a parallel double-blind randomized controlled clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100053054

Enrollment

Unknown

Registered

2021-11-10

Start date

2021-11-09

Completion date

Unknown

Last updated

2022-09-06

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

Conditions

Lumber disease

Interventions

Group A:Denosumab

Group B:Placebo

Eligibility

Sex/Gender

All

Age

40 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 40 to 90 years; 2.Clinically diagnosed with lumbar spinal stenosis; 3.Combined with osteoporosis, low back pain or numbness (MRI demonstrated signs of nerve compression).

Exclusion criteria

Exclusion criteria: 1.History of chronic kidney, liver failure, heart failure, hypocalcaemia/hypercalcemia; 2.Cancer; 3.Corticosteroid therapy; 4.Cauda cauda horse atrophy, progressive neurologic deficit; 5.Malignancy; 6.Scoliosis greater than 15 degrees; 7.Previous back surgery, and other established contraindications for elective surgery.

Design outcomes

Primary

Measure	Time frame
Osteocalcin;Procollagen type 1 N-terminal propeptide;C-terminal cross-linked type 1 collagen terminal peptide;Parathyroid hormone;Serum total calcium;Total phosphorus;Albumin;	—

Secondary

Measure	Time frame
Numeric Rating Scale for Pain;Visual analogue scale pain questionnaire;Roland Morris questionnaire;Osteoporosis questionnaire;Health index scale questionnaire;	—

Countries

China

Contacts

Public ContactWang Hongyu

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

wanghongyu790039663@126.com+86 18241651300

Outcome results

None listed

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