ArticleThe Journal of clinical endocrinology and metabolism2021
Denosumab Safety and Efficacy Among Participants in the FREEDOM Extension Study With Mild to Moderate Chronic Kidney Disease.
Article in The Journal of clinical endocrinology and metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 49 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
Who cites it
49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 87 citations in OpenAlex.
- Effects of anti-osteoporotic drugs in patients with chronic kidney disease: a systemic review and network meta-analysis of bone mineral density, clinical fracture rate and renal function.Frontiers in pharmacology · 2025Pooled it
- [Osteoporosis-Definition, risk assessment, diagnosis, prevention and treatment (update 2024) : Guidelines of the Austrian Society for Bone and Mineral Research].Wiener klinische Wochenschrift · 2024Guideline
- Long-term effects of denosumab: a 10-year single-center retrospective study.Archives of osteoporosis · 2026Article
- Preventing Hip (Proximal Femoral) Fractures: An Evidence-Based Review for Clinicians.Journal of clinical medicine · 2026Review
- Comparison of Efficacy and Safety of Denosumab with Eldecalcitol or Native Vitamin D in Postmenopausal Chinese Women with Osteoporosis (ESCORT): A Randomized Controlled Trial.Journal of clinical medicine · 2026Article
- Cardiovascular Outcomes Associated with Romosozumab Versus Denosumab in Chronic Kidney Disease.Medicina (Kaunas, Lithuania) · 2026Article
- Impact of Denosumab Adherence on Renal Function and Mortality Rates in Type 2 Diabetes Patients With Osteoporosis.The Kaohsiung journal of medical sciences · 2026Article
- Chronic kidney disease and denosumab in metastatic bone disease: A multicenter Turkish cohort study on severe hypocalcemia, skeletal events, and survival.Journal of bone oncology · 2025Article
- Comprehensive Evaluation of Treatment Patterns in Postmenopausal Patients with Osteoporosis without Fractures: Insights from Tertiary Care Institutions and Nationwide OMOP-CDM Data.Endocrinology and metabolism (Seoul, Korea) · 2025Article
- Management of osteoporosis in chronic kidney disease.Clinical kidney journal · 2025Review
- Article
- Trends in serum phosphate, calcium, and parathyroid hormone levels according to renal function following denosumab.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025Observational
- Denosumab discontinuation in the clinic: implications of rebound bone turnover and emerging strategies to prevent bone loss and fractures.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025Review
- Real-world data from a national survey on management of CKD-associated osteoporosis among Italian nephrologists.Archives of osteoporosis · 2025Article
- Bone in Parathyroid Diseases Revisited: Evidence From Epidemiological, Surgical and New Drug Outcomes.Endocrine reviews · 2025Review
- Long-Term Changes in Parameters of Bone Quality in Kidney Transplant Recipients Treated with Denosumab.Calcified tissue international · 2025Article
- Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use.Endocrinology and metabolism (Seoul, Korea) · 2025Review
- Diagnosis, evaluation and management of osteoporosis in chronic kidney disease: navigating treatment approaches - Indian consensus statement.Frontiers in nephrology · 2025Article
- Adherence to denosumab therapy and all-cause mortality in dialysis patients with osteoporosis: a retrospective cohort exploratory study.Frontiers in pharmacology · 2025Article
- Denosumab-Induced Recurrent Severe Hypocalcaemia in a Patient With Chronic Kidney Disease: A Case Report.Cureus · 2024Article
Corrections and comments
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Authors and funding
9 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextThe effects of long-term exposure to denosumab in individuals with renal insufficiency are unknown.
objectiveThis 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. PARTICIPANTS AND
methodsWomen 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.
resultsMost 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.
conclusionThe safety and efficacy of denosumab did not differ among participants with mild to moderate CKD.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.