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To compare the effects of Denosumab and Teriparatide on bone fusion and systemic bone loss, a double-blind, parallel, randomized controlled clinical trial

A randomized controlled clinical study comparing the effects of denosumab and teriparatide on lumbar spinal fusion and systemic bone loss after surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099895
Enrollment
Unknown
Registered
2025-03-31
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Osteoporosis

Interventions

Denosumab group:Desmodium subcutaneous injection 60 mg/6 months
Teriparatide group:Teriparatide subcutaneous injection 20ug/day

Sponsors

Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with single-segment degenerative lumbar spinal stenosis undergoing surgery 2. Dual-energy X-ray detection of lumbar spine bone density and/or femoral neck bone density T value <= 2.5 3. Informed and agreed to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1. Spinal tumors 2. Spinal infection 3. Vertebral fractures 4. History of spinal surgery 5. History of anti-osteoporosis drug use 6. Severe spinal deformity 7. Other physical diseases, including diabetes, severe hypertension, autoimmune diseases, heart, liver and kidney diseases, malignant tumors, mental illness and other diseases that doctors believe may affect the test process 8. Exclude primary osteoporosis, any disease that affects bone metabolism or treatment response, including serum pTH>65pg/mI, 25-hydroxyvitamin D135U/L, history of bone tumors, Paget's disease, radiotherapy history 9. Allergic to teriparatide, denosumab or any excipients 10. Hyperparathyroidism, severe renal insufficiency, hypercalcemia, hypocalcemia and other contraindications to teriparatide and denosumab

Design outcomes

Primary

MeasureTime frame
Bone fusion;Postoperative whole body bone mass and bone metabolism;

Secondary

MeasureTime frame
Loose screws;pain;

Countries

China

Contacts

Public ContactGuodong Wang

Shandong Provincial Hospital Affiliated to Shandong First Medical University

wangguodong@sdfmu.edu.cn+86 158 0641 5867

Outcome results

None listed

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