Clinical trial NCT02333344: The Efficacy Study of Aclasta on Prosthetic Fixation in Postmenopausal Women After THA
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Prosthetic Fixation After Cementless Total Hip Arthroplasty
Keywords: prosthetic fixation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: the transverse translation (μm)
timeFrame: baseline and month12,month 24
Secondary outcomes:
measure: average bone mineral density ( BMD )
timeFrame: 1w,6m,12m and 24m after THA operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: