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Clinical study of percutaneous kyphoplasty combined with zoledronic acid for the treatment of osteoporotic vertebral compression fracture

Clinical study of percutaneous kyphoplasty combined with zoledronic acid for the treatment of osteoporotic vertebral compression fracture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054015
Enrollment
Unknown
Registered
2021-12-06
Start date
2019-09-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporotic vertebral compression fracture

Interventions

Intervention group:PKP+zoledronic acid
Controlled group:PKP

Sponsors

Department of Orthopedics, Beijing University of Chinese Medicine Third Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Postmenopausal women or adult men with BMD T-score <= 2.5 or less at the lumbar spine measured by dual-energy X-ray absorptiometry (DXA); 2.Isolated compression fracture of single-level vertebral body within 4 weeks; 3.The evidences of vertebral compression fractures were shown by X-ray, and confirmed by MRI. Middle and posterior columns were not affected as shown by CT scanning; 4.Relatively severe back pain exacerbated after activities; 5.Spinal tenderness and/or vertebral body pain with percussion; and 6.Pain that did not improve with control management including bed rest, nonsteroidal anti-inflammatory drugs (NSAIDs), opioid analgesics, and bracing.

Exclusion criteria

Exclusion criteria: 1.Patients with secondary osteoporotic vertebral compression fractures; 2.Patients with symptoms of spinal cord or nerve compression needing fragment excision, decompression, open reduction and internal fixation; 3.Patients complicated with metastasis, multiple myeloma, spinal infection, spinal tuberculosis or hypocalcemia; 4.Patients with severe cardiopulmonary dysfunction, liver failure or renal insufficiency who could not tolerate surgery and anesthesia.

Design outcomes

Primary

MeasureTime frame
bone mineral density;peptide type I collagen amino end;beta collagen degradation product;osteocalcin in the N-terminal molecular fragment;Visual analogue scale;Oswestry disability index;vertebral height and Cobb angle of injured vertebrae;

Countries

China

Contacts

Public ContactKan Liu

Department of Orthopedics, Beijing University of Chinese Medicine Third Affiliated Hospital

atmlkmd@126.com+86 13146954969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026