Denosumab for Treating Periprosthetic Osteolysis.
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|ClinicalTrials.gov Identifier: NCT02299817|
Recruitment Status : Unknown
Verified February 2019 by Olof Skoldenberg, Danderyd Hospital.
Recruitment status was: Active, not recruiting
First Posted : November 24, 2014
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteolysis||Drug: Denosumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Denosumab for Treating Periprosthetic Osteolysis After Uncemented Total Hip Arthroplasty A Randomized, Double-blind, Placebo-controlled Trial Using Volumetric Computed Tomography|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||February 2021|
Active Comparator: Denosumab
Patients will receive a dose of 60 mg denosumab (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months.
Prolia is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones). In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip.
Prolia is also used to treat bone loss in men receiving treatment for prostate cancer that increases their risk of fracture. Prolia reduces the risk of fractures in the spine.
Recently denosumab was found to be effective in preventing osteoporosis related fractures in post-menopausal women by blocking RANKL and thereby inhibiting the development and activity of osteoclast.
Other Name: Prolia
Placebo Comparator: Placebo
Patients will receive a dose of placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months.
- Volume of the osteolytic lesion [ Time Frame: 3 years ]The change in volume of the osteolytic lesion over 3 years (measured with 3D-CT in cm³) is the primary endpoint variable: E〖fficacy〗_(3 years)=〖Volume〗_(3 years)-〖Volume〗_baseline.
- Volume of the osteolytic lesion [ Time Frame: 2 years ]The change in volume of the osteolytic lesion over 2 years (measured with 3D-CT in cm³) 〖Efficacy〗_(2 years)=〖Volume〗_(2 years)-〖Volume〗_baseline.
- Percentage change of the lesion over the study period [ Time Frame: 3 years ]Percentage change of the lesion over the study period
- Adverse events [ Time Frame: 3 years ]Occurrence of AE´s
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299817
|Stockholm, Sweden, 182 88|
|Study Director:||Olof Sköldenberg, MD, Ph.D||Danderyds Hospital|