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

Osteoporosis Clinical Trial

Official title:

The Effects of Denosumab on Bone Fusion and Bone Metabolism in Osteoporotic Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203588
• Other study ID #: 2021SL031
• Status: Recruiting
• Phase: Phase 4
• Start date: October 9, 2021
• Est. completion date: October 2023

Study information

• Verified date: January 2022
• Source: Shanghai Changzheng Hospital
• Contact: Lvping Sun
• Phone: 021-81885070
• Email: shczkykxs[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: October 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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).

3. Patients will be underwent single-level or two-level lumbar interbody fusion.

Exclusion Criteria:

1. Paget disease of bone,

2. Low laboratory tests for calcium,

3. Previous radiation treatment or fusion surgery to lumbar spine,

4. Bone tumors,

5. Bone infection,

6. Acute vertebral fractures

7. Severe spinal deformities such as degenerative scoliosis,

8. Other metabolic bone disease,

9. History of a anti-osteoporosis medication

10. Combined with severe morbidities,

11. Uncorrected bleeding diatheses

12. Application of steroids.

Related Conditions & MeSH terms

• Fusion of Spine, Lumbar Region
• Osteoporosis

Intervention

Drug:
• Denosumab 60 mg/ml Injectable Solution [Prolia]
Denosumab, 60mg(1ml), subcutaneously, totally two times, with one time at 1-week postoperatively and another time at 26-week postoperatively.
• calcium and vitamin D
calcium (=1·0 g) and vitamin D (=400 IU).

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bone mineral density (BMD)	BMD will be measured at the lumbar spine or femoral neck by DXA before surgery.	Pre-operation
Other	Bone mineral density (BMD)	Due to instrumentation at the lumbar site, BMD will be measured only at the femoral neck by DXA after surgery.	6-month post-operation
Other	Bone mineral density (BMD)	Due to instrumentation at the lumbar site, BMD will be measured only at the femoral neck by DXA after surgery.	12-month post-operation
Primary	lumbar fusion rate	Fusion rate assessed by CT scan and dynamic radiograph	3-month post-operation
Primary	lumbar fusion rate	Fusion rate assessed by CT scan and dynamic radiograph	6-month post-operation
Primary	lumbar fusion rate	Fusion rate assessed by CT scan and dynamic radiograph	9-month post-operation
Primary	lumbar fusion rate	Fusion rate assessed by CT scan and dynamic radiograph	12-month post-operation
Secondary	Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (ß-CTX) and osteocalcin (OCN)	To assess bone metabolism, serum samples will be collected under nonfasting conditions, and the concentrations of ß-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.	pre-operation
Secondary	Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (ß-CTX) and osteocalcin (OCN)	To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of ß-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.	3-month post-operation
Secondary	Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (ß-CTX) and osteocalcin (OCN)	To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of ß-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.	6-month post-operation
Secondary	Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (ß-CTX) and osteocalcin (OCN)	To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of ß-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.	9-month post-operation
Secondary	Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (ß-CTX) and osteocalcin (OCN)	To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of ß-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.	12-month post-operation