Strategy and clinical application to improve prosthesis survival rate based on nerve/endocrine-bone metabolism network

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200057899

Enrollment

Unknown

Registered

2022-03-21

Start date

2022-04-01

Completion date

Unknown

Last updated

2023-11-21

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

Conditions

Periprosthetic osteolysis

Interventions

therapy group:Melatonin

control group:Placebo

Eligibility

Sex/Gender

Female

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Women with primary osteoporosis (BMD = - 2.5); 2. Patients with femoral neck and intertrochanteric fractures; 3. The first TJA implant biological prosthesis; Renal function and blood calcium level were normal; No history of allergy to calcium tablets and calcitriol; 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with hip joint revision; 2. Patients with renal insufficiency and hypocalcemia; Allergic history of calcium tablets and calcitriol; 3. Patients with bone metabolism related diseases or taking drugs that affect bone metabolism for a long time; 4. Implantation of cement prosthesis.

Design outcomes

Primary

Measure	Time frame
sex;age;height;weight;BMI;radiographic outcomes;bone density;bone biochemistry;Oxidative stress index;	—

Countries

China

Contacts

Public ContactDechun Geng

the First Affiliated Hospital of Soochow University

szgengdc@suda.edu.cn+86 13915439672

Outcome results

None listed

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