UnknownNot Applicable

Denosumab vs Alendronate After Vertebroplasty

China90 participantsStarted 2021-01-03

Plain-language summary

Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and alendronate is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP

Who can participate

Age range50 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must be age between 50 and 85 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 Exclusion Criteria: * 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

What they're measuring

Lumbar bone mineral density(BMD)

Timeframe: up to 12 months

Total hip BMD

Timeframe: up to 12 months

Femoral neck BMD

Timeframe: up to 12 months

Procollagen type 1 n-terminal propeptide (P1NP)

Timeframe: up to 12 months

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

Timeframe: up to 12 months

Visual analog scale (VAS) back

Timeframe: up to 12 months

Trial details

NCT IDNCT05662358

SponsorShenzhen People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-20

Contact for this trial

Hongyu Wang, Doctor

18241651300 wanghongyu790039663@126.com

View on ClinicalTrials.gov More Denosumab Allergy trials

Plain-language summary

Who can participate

Age range50 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Lumbar bone mineral density(BMD)

Timeframe: up to 12 months

Total hip BMD

Timeframe: up to 12 months

Femoral neck BMD

Timeframe: up to 12 months

Procollagen type 1 n-terminal propeptide (P1NP)

Timeframe: up to 12 months

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

Timeframe: up to 12 months

Visual analog scale (VAS) back

Timeframe: up to 12 months