Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women (NCT01926158) | Clinical Trial Compass
CompletedPhase 4
Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women
Finland65 participantsStarted 2013-12
Plain-language 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 investigators assume that denosumab prevents periprosthetic bone loss and enhances bone bonding of the hip stem in postmenopausal women.
Who can participate
Age range60 Years – 85 Years
SexFEMALE
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Inclusion Criteria:
* Postmenopausal women, age: ≥ 60 years to ≤ 85 years at randomization
* Degenerative primary hip osteoarthritis 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
* cinacalcet
* aluminum
* lithium
* protease inh…