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

• Status: Withdrawn
• Trial end date: 2020-01-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

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.

Other protocol-defined inclusion/exclusion criteria may apply