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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patients in this group are received denosumab (60 mg) subcutaneously at one week and 26 weeks after the lumbar fusion surgery, combined with receiving daily calcium (≥1·0 g) and vitamin D (≥400 IU). |
|
| Control group | Sham Comparator | Patients in this group are only received daily calcium (≥1·0 g) and vitamin D (≥400 IU) after the lumbar fusion surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab 60 mg/ml Injectable Solution [Prolia] | Drug | Denosumab, 60mg(1ml), subcutaneously, totally two times, with one time at 1-week postoperatively and another time at 26-week postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| lumbar fusion rate | Fusion rate assessed by CT scan and dynamic radiograph | 3-month post-operation |
| lumbar fusion rate | Fusion rate assessed by CT scan and dynamic radiograph | 6-month post-operation |
| lumbar fusion rate | Fusion rate assessed by CT scan and dynamic radiograph | 9-month post-operation |
| lumbar fusion rate | Fusion rate assessed by CT scan and dynamic radiograph | 12-month post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN) | To assess bone metabolism, serum samples will be collected under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively. | pre-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density (BMD) | BMD will be measured at the lumbar spine or femoral neck by DXA before surgery. | Pre-operation |
| Bone mineral density (BMD) | Due to instrumentation at the lumbar site, BMD will be measured only at the femoral neck by DXA after surgery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lvping Sun | Contact | 021-81885070 | shczkykxs@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Changgui Shi, M.D. | Shanghai changzheng hospital, Naval Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200003 | China |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| calcium and vitamin D | Drug | calcium (≥1·0 g) and vitamin D (≥400 IU). |
|
| Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN) | To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively. | 3-month post-operation |
| Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN) | To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively. | 6-month post-operation |
| Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN) | To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively. | 9-month post-operation |
| Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN) | To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively. | 12-month post-operation |
| 6-month post-operation |
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |