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

NCT ID: NCT02333344

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-30
• Study Completion Date: 2020-01-28

Brief 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.

Detailed 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.

Conditions

Prosthetic Fixation After Cementless Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zoledronic acid 5mg

interventional group which receive yearly Zoledronic acid 5mg/100ml infusion treatment for two years

Group Type: EXPERIMENTAL

Zoledronic acid 5mg

Intervention Type: DRUG

two-year Zoledronic acid 5mg infusion treatment

blank

blank group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Zoledronic acid 5mg

two-year Zoledronic acid 5mg infusion treatment

Intervention Type: DRUG

Other Intervention Names

aclasta

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CZOL446HCN13

Identifier Type: -

Identifier Source: org_study_id