The Efficacy Study of Aclasta on Prosthetic Fixation in Postmenopausal Women After THA

Prosthetic Fixation After Cementless Total Hip Arthroplasty Clinical Trial

Official title:

The Efficacy Study of Aclasta (Zoledronic Acid 5mg) on Prosthetic Fixation in Postmenopausal Women After Cementless Total Hip Arthroplasty (THA): a 24 Months, Single Center, Open- Label, Randomized, Parallel Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02333344
• Other study ID #: CZOL446HCN13
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 30, 2015
• Est. completion date: January 28, 2020

Study information

• Verified date: September 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after 24-month observation.

Description:

To investigate the efficacy of Zoledronic acid and placebo treatment on the prosthetic transverse translation in post-menopausal osteoporosis women under cementless total hip arthroplasty by Radiostereometry （RSA）in two-year follow-up period .

Meanwhile to assess efficacy of Zoledronic acid treatment on the vertical translation of acetabulum and the subsidence translation of femoral stem by Radiostereometry（RSA), prevention of peri- prosthetic bone loss by observing the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA）scans, et al.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients who was diagnosed with Post-menopausal osteoporosis( bone mineral density T<-2.5;or with previous fragility fracture, bone mineral density T -2.5~-1.5), responding to Zoledronic acid, within one week after the successful cementless total hip arthroplasty surgery.

Exclusion Criteria:

1. Patients with any history of disorders except osteoporosis known to severely affect bone and mineral metabolism such as Paget disease;

2. Patients who suffer from secondary osteoporosis

3. Patients who were treated with bisphosphonate within the previous one year ,anabolic drug or strontium;

4. Patients with contraindications for Zoledronic acid:

5. Patients with invasive malignant tumor on any organ in the past 5 years, treated oruntreated;

6. Patients with primary hyperparathyroidism.

7. Serum calcium >2.75mmol/L (11.0mg/dL).

8. Patients who are unwilling to accept the treatment of Zoledronic acid.

9. Patients who accepted the treatment of investigational product and/or device in the 30 days before randomization.

10. Patients with any medical or mental diseases, which prevent patients from complying with protocols or completing protocols, judged by investigators.

11. Patients with the medical history of inflammation of the iris or uveitis, except the inflammation which is secondary to trauma and cured 2 years ago before screening.

12. Patients with the medical history of diabetic nephropathy or diabetic retinopathy.

13. Patients aged under 60 years old and whose result of urine pregnancy test paper is positive.

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Prosthetic Fixation After Cementless Total Hip Arthroplasty

Intervention

Drug:
• Zoledronic acid 5mg
two-year Zoledronic acid 5mg infusion treatment

Locations

Country	Name	City	State
China	Novartis Investigative Site	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the transverse translation (µm)	the transverse translation (µm, outside-inside) between acetabular prosthesis markers and reference point	baseline and month12,month 24
Secondary	average bone mineral density ( BMD )	the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA)scans.	1w,6m,12m and 24m after THA operation