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Efficacy and safety of denosumab in promoting osseointegration of the prosthesis after total hip arthroplasty in elderly postmenopausal women with osteoporosis: a prospective real-world study

Efficacy and safety of denosumab in promoting osseointegration of the prosthesis after total hip arthroplasty in elderly postmenopausal women with osteoporosis: a prospective real-world study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086266
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Hip Arthroplasty

Interventions

Case series:None

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age =60, =75 years, female; 2) BMD of lumbar spine or hip (assessed by QCT or DXA): -4.0 < T = -2.5; 3) Hip diseases such as femoral neck fracture, osteoarthritis of the hip or necrosis of the femoral head. 3) Patients who need to undergo total hip replacement due to hip diseases such as femoral neck fracture, osteoarthritis of the hip or necrosis of the femoral head; 4) The surgical prosthesis is to be a bioprosthesis; 5) Patients who are going to receive basic treatment with deslumizumab or bisphosphonates or only basic treatment; 6) Patients who voluntarily sign an informed consent form

Exclusion criteria

Exclusion criteria: 1) Patients with contraindications to total hip arthroplasty; 2) malignant tumors, bone infections, Paget's disease of bone or other endocrine diseases that cannot be controlled by medical therapy or other diseases that have a serious effect on bone metabolism (e.g. hyperparathyroidism, hyperparathyroidism, etc.); 3) Contraindications to the use of deslizumab, such as hypocalcemia, hypersensitivity to the active ingredient or to any of the excipients; 4) Patients who have received anti-osteoporosis treatment with deslumizumab, teriparatide or romozolomide within 12 months prior to enrollment; 5) Patients who intend to receive other anti-osteoporotic therapy such as teriparatide or romozolomide during the study period; 6) Patients who are assessed by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Osteointegration rate of prosthesis at 12 months postoperatively;

Secondary

MeasureTime frame
Bone density at 6 and 12 months after surgery;Prosthesis loosening rate at 3, 6, and 12 months postoperatively;Height of prosthesis subsidence at 3, 6 and 12 months after surgery;Bone turnover indexes at 3, 6, and 12 months after surgery;Postoperative Harris score at 3, 6, 12 months;WOMAC arthritis score at 3, 6, and 12 months after surgery;Electrolyte levels;Adverse Events;

Countries

China

Contacts

Public ContactZhang Bin

The First Affiliated Hospital of Nanchang University

zb76@tom.com+86 139 7082 3907

Outcome results

None listed

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