Desomumab vs Zoledronic Acid and Osteoporotic Compression Fracture

Sponsor
Shenzhen People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05106517
Collaborator
(none)
122
1
2
13.1
9.3

Study Details

Study Description

Brief Summary

Bone mineral density and function at 1 year after screw fixation with desomumab vs zoldronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function of osteoporotic vertebral compression fracture (OVCF) were compared 1 year after screw internal fixation with desomumab vs zoledronic acid in Shenzhen People's Hospital from September, 2021 to November, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Attending Physician of Shenzhen People's Hospital
Actual Study Start Date :
Sep 8, 2021
Anticipated Primary Completion Date :
Sep 12, 2022
Anticipated Study Completion Date :
Oct 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: dnosumab

Desomumab 60mg/6 months subcutaneously + placebo intravenous

Drug: Denosumab
Desomumab 60mg/6 months subcutaneously + placebo iv
Other Names:
  • Denosumab 6 month/subcutaneous
  • Experimental: zoledronic acid

    intravenous zoledronic acid and placebo /6 months subcutaneously

    Drug: Zoledronic acid
    Iv zoledronic acid and placebo /6 months subcutaneously
    Other Names:
  • Zoledronic acid intravenous once a year
  • Outcome Measures

    Primary Outcome Measures

    1. age [up to 12 months]

      participants age

    2. sex [up to 12 months]

      participants sex

    3. height [up to 12 months]

      participants height cm

    4. BMI [up to 12 months]

      participants body mass index

    5. serum osteocalcin [up to 12 months]

      osteocalcin in the N terminal molecular fracgment

    6. serum P1NP [up to 12 months]

      Procollagen type 1 n-terminal propeptide

    7. serum CTX [up to 12 months]

      C-terminal cross-linked type 1 collagen terminal peptide

    8. Serum total calcium [up to 12 months]

      Serum total calcium level

    9. serum PTH [up to 12 months]

      serum parathyroid hormone level

    10. serum total phosphorus level [up to 12 months]

      serum total phosphorus level

    11. serum tALP [up to 12 months]

      serum total alkaline phosphatase

    12. serum Albumin [up to 12 months]

      serum albumin level

    13. lumber spine bone mineral density [up to 12 months]

      DEXA for lumber spine bone mineral density

    14. hip bone mineral density [up to 12 months]

      DEXA for hip bone mineral density

    15. MRI for lumber [up to 12 months]

      Bone marrow edema and adjacent intervertebral disc were detected by MRI

    16. Numerical Rating Scale (NRS) [up to 12 months]

      The NRS is a segmented numerical version of the VAS in which a respondent selects a whole number (0- 10) that best reflects the intensity of the pain

    17. Verbal Rating Scales (VRS) [up to 12 months]

      VRS use categories to differentiate pain intensity. There is a wide variability of terms used to describe each category and the rating may be divided into four (0 -3) or six (0 -5) categories. Patients score their pain intensity from absent (0) to severe (3) or from none (0) to very severe (5)

    Secondary Outcome Measures

    1. The Roland-Morris Disability Questionnaire [up to 12 month]

      The RDQ is a health status measure designed to be completed by patients to assess physical disability due to low back pain.

    2. QUALEFFO-31 [up to 12 month]

      Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) was developed in 1997 to evaluate HRQoL for patients with osteoporosis. The questionnaire assesses quality of life in the aspect of pain, physical function, social function, general health, and mental health

    3. EuroQol-5D (EQ-5D) [up to 12 month]

      EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Must be age between 40 and 90 years old

    • X-ray diagnosis of 1-2 vertebral compression fractures

    • DEXA test BMD T value was less than -1

    • fracture history lasted within 6 weeks

    • Must be MRI showed bone marrow edema of injured segment

    • Must be lower back pain, local spines tenderness

    Exclusion Criteria:
    • Must be able to have no posterior vertebral wall fracture

    • Must be able to have no patients with 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 calcium level ≤2.13 mmol/L

    • 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 surgery

    • Must be able to have no other established contraindications for elective surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ShenzhenPH Shenzhen Guangdong China 518000

    Sponsors and Collaborators

    • Shenzhen People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shenzhen People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05106517
    Other Study ID Numbers:
    • ShenzhenPH spine wang04
    First Posted:
    Nov 3, 2021
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021