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Denosumab Safety and Efficacy Among Participants in the FREEDOM Extension Study With Mild to Moderate Chronic Kidney Disease.
- Source :
-
The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2021 Jan 23; Vol. 106 (2), pp. 397-409. - Publication Year :
- 2021
-
Abstract
- Context: The effects of long-term exposure to denosumab in individuals with renal insufficiency are unknown.<br />Objective: This post hoc analysis evaluates the long-term safety and efficacy of denosumab in individuals with mild-to-moderate chronic kidney disease (CKD) (stages 2 and 3) using data from the pivotal phase 3, double-blind, 3-year FREEDOM (NCT00089791) and open-label, 7-year extension (NCT00523341) studies.<br />Participants and Methods: Women age 60 to 90 years with a bone mineral density (BMD) T-score of less than -2.5 to greater than -4.0 at the total hip or lumbar spine were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months (long-term arm) or placebo (cross-over arm) in FREEDOM; eligible participants could enroll in the extension to receive denosumab 60 mg subcutaneously every 6 months. Change in estimated glomerular filtration rate (eGFR) from study baseline and annualized rates of fracture and adverse events (AEs) were the main outcome measures.<br />Results: Most participants (1259/1969 [64%] long-term arm; 1173/1781 [66%] crossover arm) with baseline CKD stage 2 or 3 remained within the same CKD subgroup at study completion; less than 3% progressed to CKD stage 4. Participants in all eGFR subgroups showed similar, persistent BMD gains over time and a low incidence of fractures. The percentage of participants reporting serious AEs was similar among renal subgroups (normal, CKD stage 2, CKD stage 3a, CKD stage 3b) both for the long-term (54% vs 52% vs 57% vs 58%) and crossover (43% vs 42% vs 43% vs 68%) arms, except CKD stage 3b subgroup, crossover arm.<br />Conclusion: The safety and efficacy of denosumab did not differ among participants with mild to moderate CKD.<br /> (© The Author(s) 2020. Published by Oxford University Press on behalf of the Endocrine Society.)
- Subjects :
- Aged
Aged, 80 and over
Bone Density Conservation Agents adverse effects
Clinical Trials, Phase III as Topic
Cross-Over Studies
Denosumab adverse effects
Double-Blind Method
Female
Follow-Up Studies
Fractures, Bone chemically induced
Global Health
Humans
Hypocalcemia chemically induced
Middle Aged
Multicenter Studies as Topic
Osteoporosis, Postmenopausal chemically induced
Prognosis
Randomized Controlled Trials as Topic
Renal Insufficiency, Chronic pathology
Bone Density
Bone Density Conservation Agents administration & dosage
Denosumab administration & dosage
Fractures, Bone pathology
Hypocalcemia pathology
Osteoporosis, Postmenopausal pathology
Renal Insufficiency, Chronic drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1945-7197
- Volume :
- 106
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- The Journal of clinical endocrinology and metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 33211870
- Full Text :
- https://doi.org/10.1210/clinem/dgaa851