Denosumab and Screw Fixation for Osteoporotic Compression Fracture
Study Details
Study Description
Brief Summary
Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: 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 were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: dnosumab Desuzumab 60 mg subcutaneously /6 months, twice a year |
Drug: Denosumab
denosumab subcutaneous injection /6 months, twice a year
|
| Placebo Comparator: placebo control Placebo subcutaneous injection /6 months, twice a year |
Drug: Denosumab
denosumab subcutaneous injection /6 months, twice a year
|
Outcome Measures
Primary Outcome Measures
- age [up to 12 months]
participants age (year)
- sex [up to 12 months]
participants sex
- height [up to 12 months]
participants height cm
- weight [up to 12 months]
participants weight kg
- BMI [up to 12 months]
participants body mass index
- osteocalcin [up to 12 months]
osteocalcin in the N terminal molecular fragment
- P1NP [up to 12 months]
Procollagen type 1 n-terminal propeptide
- CTX [up to 12 months]
C-terminal cross-linked type 1 collagen terminal peptide
- Serum total calcium [up to 12 months]
Serum total calcium level
- parathyroid hormone [up to 12 months]
serum parathyroid hormone level
- tALP [up to 12 months]
serum total alkaline phosphatase
- albumin [up to 12 months]
serum albumin level
- lumber spine bone mineral density [up to 12 months]
DEXA for lumber spine bone mineral density
- Hip bone mineral density [up to 12 months]
DEXA for hip bone mineral density
- MRI of lumber [up to 12 months]
Bone marrow edema and adjacent intervertebral disc were detected by MRI
- Numerical Rating Scale [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
- Verbal Rating Scales (VRS) [up to 12 months]
VRSs 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
- 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.
- 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
- EuroQol-5D (EQ-5D): an instrument for measuring quality of life [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
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
-
MRI showed bone marrow edema of injured segment
-
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 previous use of anti-osteoporosis drugs within 6 weeks
-
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.- ShenzhenPH spine wang02