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 range
60 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.