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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prosthetic Fixation After Cementless Total Hip Arthroplasty
• Intervention / Treatment: Drug: Zoledronic acid 5mg

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zoledronic acid 5mg; interventional group which receive yearly Zoledronic acid 5mg/100ml infusion treatment for two years	Drug: Zoledronic acid 5mg; two-year Zoledronic acid 5mg infusion treatment; Other Names: aclasta
No Intervention: blank; blank group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the transverse translation (μm)	the transverse translation (μm, outside-inside) between acetabular prosthesis markers and reference point	baseline and month12,month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2015
• Primary Completion (Anticipated): January 28, 2020
• Study Completion (Anticipated): January 28, 2020

Study Registration Dates

• First Submitted: October 12, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: prosthetic fixation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: CZOL446HCN13