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

Novartis

Status and phase

Withdrawn

Phase 4

Conditions

Prosthetic Fixation After Cementless Total Hip Arthroplasty

Treatments

Drug: Zoledronic acid 5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02333344

CZOL446HCN13

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

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

Patients with any history of disorders except osteoporosis known to severely affect bone and mineral metabolism such as Paget disease;
Patients who suffer from secondary osteoporosis
Patients who were treated with bisphosphonate within the previous one year ,anabolic drug or strontium;
Patients with contraindications for Zoledronic acid:
Patients with invasive malignant tumor on any organ in the past 5 years, treated oruntreated;
Patients with primary hyperparathyroidism.
Serum calcium >2.75mmol/L (11.0mg/dL).
Patients who are unwilling to accept the treatment of Zoledronic acid.
Patients who accepted the treatment of investigational product and/or device in the 30 days before randomization.
Patients with any medical or mental diseases, which prevent patients from complying with protocols or completing protocols, judged by investigators.
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.
Patients with the medical history of diabetic nephropathy or diabetic retinopathy.
Patients aged under 60 years old and whose result of urine pregnancy test paper is positive.