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

NCT02333344 | Withdrawn Phase 4

• 1 other identifier: CZOL446HCN13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthetic Fixation After Cementless Total Hip Arthroplasty

Keywords

prosthetic fixation

Outcome Measures

Primary Outcomes (1)

• the transverse translation (μm)

  the transverse translation (μm, outside-inside) between acetabular prosthesis markers and reference point

  baseline and month12,month 24

Secondary Outcomes (1)

• average bone mineral density ( BMD )

  1w,6m,12m and 24m after THA operation

Study Arms (2)

Zoledronic acid 5mg

EXPERIMENTAL

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

Drug: Zoledronic acid 5mg

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NO INTERVENTION

blank group

Interventions

Zoledronic acid 5mg DRUG

two-year Zoledronic acid 5mg infusion treatment

Also known as: aclasta

Zoledronic acid 5mg

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2014
• First Posted: January 7, 2015
• Study Start: July 30, 2015
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

CN (1)