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

NCT05203588 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 2021SL031
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Fusion of Spine, Lumbar Region

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)

  pre-operation

• Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)

  3-month post-operation

• Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)

  6-month post-operation

• Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)

  9-month post-operation

• Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)

  12-month post-operation

Other Outcomes (3)

• Bone mineral density (BMD)

  Pre-operation

• Bone mineral density (BMD)

  6-month post-operation

• Bone mineral density (BMD)

  12-month post-operation

Study Arms (2)

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).

Drug: Denosumab 60 mg/ml Injectable Solution [Prolia]; Drug: calcium and vitamin D

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.

Drug: calcium and vitamin D

Interventions

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.

Experimental group

calcium and vitamin D DRUG

calcium (≥1·0 g) and vitamin D (≥400 IU).

Control group; Experimental group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Paget disease of bone,
• Low laboratory tests for calcium,
• Previous radiation treatment or fusion surgery to lumbar spine,
• Bone tumors,
• Bone infection,
• Acute vertebral fractures
• Severe spinal deformities such as degenerative scoliosis,
• Other metabolic bone disease,
• History of a anti-osteoporosis medication
• Combined with severe morbidities,
• Uncorrected bleeding diatheses
• Application of steroids.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab; Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Changgui Shi, M.D.

  Shanghai changzheng hospital, Naval Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lvping Sun

CONTACT

021-81885070; shczkykxs@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 24, 2022
• Study Start: October 9, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)