Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women
Information source: Turku University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hip Osteoarthritis
Intervention: Denosumb (Drug); Placebo (for denosumab) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Turku University Hospital Official(s) and/or principal investigator(s): Hannu T Aro, MD, PhD, Principal Investigator, Affiliation: Turku University Hospital
Overall contact: Hannu T Aro, MD, PhD, Phone: +358-40-3537644, Email: hannu.aro@utu.fi
Summary
This randomized clinical trial will evaluate the efficacy of an antiresorptive osteoporosis
drug (denosumab) in prevention of periprosthetic bone loss and in promotion of implant
osseointegration (bone bonding) in postmenopausal women after total hip replacement. The
patients with low bone mineral density (BMD) and those with normal BMD will be analyzed in
separate groups. The investigators assume that denosumab prevents periprosthetic bone loss
and enhances bone bonding of the hip stem in women with osteoporosis.
Clinical Details
Official title: Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: DXA measurement of periprosthetic BMD
Secondary outcome: RSA measurement of prosthesis stem migration
Detailed description:
This is a randomized, double-blind and placebo-controlled trial to evaluate the efficacy of
denosumab on the biologic incorporation of cementless hip prosthesis. The study population
consists of sixty-eight postmenopausal female patients, who are scheduled to have cementless
total hip replacement (THA) for primary hip osteoarthritis. The patients will be stratified
based on preoperative DXA screening of systemic bone mineral density (BMD). Patients with
normal BMD and patients with low BMD (T-score less than - 2) will be randomized within their
own stratum. The patients will be randomly assigned to receive a subcutaneous injection of
denosumab 60 mg or placebo four weeks before surgery and 22 weeks after surgery. The primary
hypothesis is that denosumab is effective in preventing periprosthetic bone loss in the
proximal femur as measured by DXA. The secondary hypothesis is that denosumab is effective
in enhancement of bone bonding (osseointegration) of cementless femoral stems, as measured
by model-based radiostereometric analysis.
Eligibility
Minimum age: 65 Years.
Maximum age: 85 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal women, age: ≥ 60 years to ≤ 85 years at randomization
- Degenerative primary hip OA as the indication of hip replacement
- Signed informed consent
Exclusion Criteria:
- Presence of severe osteoporosis (T-score less than -4. 0 and a previous fracture)
- Presence of Dorr C-type geometric change of the proximal femur
- Evidence of secondary osteoporosis
- Clinical or laboratory evidence of hepatic disease
- Laboratory evidence of hypocalcaemia
- Vitamin D deficiency (serum 25-OH(D) < 12 ng/mL)
- Disorders of parathyroid function
- Uncontrolled hyperthyroidism or hypothyroidism
- History of malignancy, radiotherapy or chemotherapy for malignancy (except basal cell
carcinoma of the skin) within the last 5 years
- History of osteonecrosis of the jaw
- History of recent tooth extraction or other dental surgery and/or invasive dental
work planned in the next 2 years
- Severe asthma or chronic obstructive pulmonary disease
- History of solid organ or bone marrow transplant
- Use within 12 months of drugs that affect bone metabolism such as ant-osteoporotic
agents (including SERMS), estrogens, testosterone, and anti-epileptics:
- Cumulative dose of 500 mg prednisone or equivalent within the last 6 months
- Ever use of oral or iv bisphosphonates
- Ever use of strontium ranelate or fluoride
- Use of the following medications:
- chronic systemic ketoconazole
- androgens
- ACTH
- cinacalcet
- aluminum
- lithium
- protease inhibitors
- gonadotropin-releasing hormone agonists
- Rheumatoid arthritis or any other inflammatory arthritis
- History of skeletal disorder, such as Paget's disease or osteomalacia
- Alcohol abuse
- General
- Mental, neurological or other conditions that may affect the ability to perform
functional or clinical assessments required by the protocol
- Subjects with known sensitivity or intolerance to any of the products to be
administered (calcium and D-vitamin supplements, denosumab)
- Subject will not be available for protocol-required study visits, to the best of
the subject's and investigator's knowledge
- Any other condition that, in the judgement of the investigator, may compromise
the ability of the subject to give written informed consent and/or to comply
with all required study procedures
Locations and Contacts
Hannu T Aro, MD, PhD, Phone: +358-40-3537644, Email: hannu.aro@utu.fi
Turku University Hospital, Turku 20521, Finland; Recruiting Hannu T Aro, MD, PhD, Phone: +358-40-3537644, Email: hannu.aro@utu.fi Lotta Polviander, PT, Phone: +358-50-4381824, Email: lotta.polviander@tyks.fi Hannu T Aro, MD, PhD, Principal Investigator
Additional Information
Orthopaedic Research Unit
Related publications: Aro HT, Alm JJ, Moritz N, Mäkinen TJ, Lankinen P. Low BMD affects initial stability and delays stem osseointegration in cementless total hip arthroplasty in women: a 2-year RSA study of 39 patients. Acta Orthop. 2012 Apr;83(2):107-14. doi: 10.3109/17453674.2012.678798. Epub 2012 Apr 11. Moritz N, Alm JJ, Lankinen P, Mäkinen TJ, Mattila K, Aro HT. Quality of intertrochanteric cancellous bone as predictor of femoral stem RSA migration in cementless total hip arthroplasty. J Biomech. 2011 Jan 11;44(2):221-7. doi: 10.1016/j.jbiomech.2010.10.012. Epub 2010 Nov 11. Alm JJ, Mäkinen 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. Mäkinen TJ, Alm JJ, Laine H, Svedström 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. Epub 2007 Jan 17. Mäkinen 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.
Starting date: December 2013
Last updated: January 7, 2014
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