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About
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 investigators assume that denosumab prevents periprosthetic bone loss and enhances bone bonding of the hip stem in postmenopausal women.
Full 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 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
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:
Use of the following medications:
Rheumatoid arthritis or any other inflammatory arthritis
History of skeletal disorder, such as Paget's disease or osteomalacia
Alcohol abuse
General
Primary purpose
Allocation
Interventional model
Masking
65 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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