Denosumab and Osteoporotic Vertebral Compression Fracture

NCT05058443 | Completed Phase 2 DMC

• 1 other identifier: ShenzhenPH spine
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.

Conditions

Osteoporotic Vertebral Compression Fracture

Keywords

denosumab; vertebroplasty

Outcome Measures

Primary Outcomes (6)

• Procollagen type 1 n-terminal propeptide (P1NP)

  Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery.

  up to 12 months

• C-terminal cross-linked type 1 collagen terminal peptide (CTX)

  Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery

  up to 12 months

• Lumbar bone mineral density(BMD)

  Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.

  up to 12 months

• Total hip BMD

  Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.

  up to 12 months

• Femoral neck BMD

  Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray

  up to 12 months

• Visual analog scale (VAS) back

  The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.

  up to 12 months

Secondary Outcomes (5)

• The Roland-Morris Disability Questionnaire

  up to 12 month

• The QUALEFFO-31 Questionnaire

  up to 12 month

• The EQ-5D Questionnaire

  up to 12 month

• Secondary fracture rate

  up to 12 month

• Adverse events

  up to 12 month

Study Arms (2)

Denosumab

EXPERIMENTAL

Denosumab 60 mg were injected subcutaneously every 6 months (Q6M)

Drug: Denosumab 60 mg/ml [Prolia]

Placebo

PLACEBO COMPARATOR

Equal volume of saline (0.9%) as placebo were injected subcutaneously every 6 months (Q6M)

Drug: Placebo

Interventions

Denosumab 60 mg/ml [Prolia] DRUG

denosumab subcutaneously every 6 months (Q6M)

Also known as: Denosumab

Denosumab

Placebo DRUG

placebo subcutaneously every 6 months (Q6M)

Also known as: equal volume of saline (0.9%)

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be age between 50 and 90 years old
• X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
• Bone mineral density T value less than -1 via dual-energy X-ray
• A recent fracture history less than 6 weeks
• MRI show bone marrow edema of fractured vertebrae
• low back pain, local paravertebral tenderness

You may not qualify if:

• Must be able to have no intervertebral fissure
• Must be able to have no infection
• Must be able to have no malignancy
• Must be able to have no neurological dysfunction
• Must be able to have no previous use of anti-osteoporosis drugs
• Must be able to have no inability to perform magnetic resonance imaging
• Must be able to have no prior back open surgery
• Must be able to have no other established contraindications for elective surgery

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

ShenzhenPH

Shenzhen, Guangdong, 518000, China

Location

Related Publications (3)

• Chang R, Qian X, Xuan Z, Xu Y, Chen Y, Gu H, Fu C. Health related quality of life and its impacts by chronic diseases in urban community population, Shanghai, China in 2015. Psychol Health Med. 2021 Sep;26(8):931-939. doi: 10.1080/13548506.2020.1856896. Epub 2020 Dec 11.

  PMID: 33305593 RESULT

• Zhou C, Li Q, Huang S, Fan L, Wang B, Dai J, Tang X. Validation of the simplified Chinese version of the quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-31). Eur Spine J. 2016 Jan;25(1):318-324. doi: 10.1007/s00586-015-4066-z. Epub 2015 Jun 14.

  PMID: 26070551 RESULT

• Stevens ML, Lin CC, Maher CG. The Roland Morris Disability Questionnaire. J Physiother. 2016 Apr;62(2):116. doi: 10.1016/j.jphys.2015.10.003. Epub 2015 Dec 11. No abstract available.

  PMID: 26687949 RESULT

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiao Xiao, Doctor

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: January 6, 2020
• Primary Completion: August 5, 2022
• Study Completion: August 10, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)