Efficacy of Zoledronic Acid in Enhancement of Early Stability of Cementless Primary Hip Prosthesis

NCT01218035 | Completed Phase 4 DMC

• 1 other identifier: 94/180/2006
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind and placebo-controlled study to evaluate the efficacy of zoledronic acid on the biologic incorporation of cementless hip prosthesis in postmenopausal female patients.The study population consists of postmenopausal female patients scheduled for total hip replacement because of degenerative hip osteoarthritis. The patients will receive either a single dose of 5 mg zoledronic acid or placebo intravenously after surgery before hospital discharge. The patients will be followed-up for 1 year. Zoledronic acid therapy has been shown to promote bone ingrowth into porous implants in pre-clinical models. The investigators hypothesis is that zoledronic acid, given as a single intravenous infusion after hip replacement surgery, enhances bone ingrowth into porous surface of cementless hip prostheses. As a primary outcome, the therapy is expected to reduce periprosthetic bone loss measured by DXA. Enhancement of bone ingrowth is expected to increase primary stability of the hip prosthesis and this effect can be detected with high-precision three-dimensional RSA imaging modality and in a faster functional recovery of the patients.

Conditions

Hip Osteoarthritis

Keywords

Hip osteoarthritis; Bisphophonate therapy; Zoledronic acid; Radiostereometric analysis; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to test whether a single infusion of zoledronic acid reduces periprosthetic bone loss measured by DXA.

  12 months

Secondary Outcomes (1)

• RSA outcome, functional recovery and metabolic treatment response

  12 months

Interventions

zoledronic acid DRUG

The patients in the active-treatment group will receive a single 5 mg dose of zoledronic acid intravenously just prior to release from the hospital (about 5th day post-surgery) as an adjunct therapy. The control group will receive a placebo (saline) infusion. All infusions will be given 100 ml in volume and infused over a period of 15 minutes with a pre- and post-infusion flush with normal saline.

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Degenerative hip osteoarthritis as the indication for hip replacement
• Postmenopausal female patient
• Age of at least 20 years
• Signed Informed Consent

You may not qualify if:

• Evidence of secondary osteoporosis
• Clinical or laboratory evidence of hepatic or renal disease
• Disorders of parathyroid function, or D-vitamin metabolism
• History of malignancy, radiotherapy, or chemotherapy for malignancy (except for basal cell carcinoma of the skin) within the past 5 years
• No metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
• Administration for more than 7 days of drugs, which may interfere with bone metabolism:
• cumulative dose of 500 mg of prednisone or equivalent within the last 6 months
• calcitonin within the last 6 months
• bisphosphonates for 30 days or more within the last 12 months
• bone therapeutic doses of fluoride for 30 days or more within the last 24 months
• Rheumatoid arthritis or any other inflammatory arthritis
• History of osteogenesis imperfecta, multiple myeloma, or Paget's disease
• Active primary hyperparathyroidism
• History of uveitis, iritis, or chronic conjunctivitis
• History of retinopathy or nephropathy, especially in the presence of uncontrollable IDDM (Hb1AC \> 10%)

Sponsors & Collaborators

• Turku University Hospital: lead
• Academy of Finland: collaborator
• Novartis: collaborator
• Stryker Nordic: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (3)

• Makinen TJ, Alm JJ, Laine H, Svedstrom E, Aro HT. The incidence of osteopenia and osteoporosis in women with hip osteoarthritis scheduled for cementless total joint replacement. Bone. 2007 Apr;40(4):1041-7. doi: 10.1016/j.bone.2006.11.013. Epub 2007 Jan 17.

  PMID: 17239668 BACKGROUND

• Makinen TJ, Koort JK, Mattila KT, Aro HT. Precision measurements of the RSA method using a phantom model of hip prosthesis. J Biomech. 2004 Apr;37(4):487-93. doi: 10.1016/j.jbiomech.2003.09.004.

  PMID: 14996560 BACKGROUND

• Alm JJ, Makinen TJ, Lankinen P, Moritz N, Vahlberg T, Aro HT. Female patients with low systemic BMD are prone to bone loss in Gruen zone 7 after cementless total hip arthroplasty. Acta Orthop. 2009 Oct;80(5):531-7. doi: 10.3109/17453670903316801.

  PMID: 19916684 BACKGROUND

Related Links

• Orthopaedic Research Unit

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hannu T Aro, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

FI (1)