Trial reportThe Journal of clinical endocrinology and metabolism2018
Effects of Long-Term Denosumab on Bone Histomorphometry and Mineralization in Women With Postmenopausal Osteoporosis.
Trial report in The Journal of clinical endocrinology and metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00523341 (An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab), which is not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
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
42 citing papers in PubMed, 1 synthesis or guideline pooled it, 94 citations in OpenAlex.
- Clinical Data for Parametrization ofFrontiers in bioengineering and biotechnology · 2022Pooled it
- Palopegteriparatide for adults with chronic hypoparathyroidism: skeletal dynamics through 3 years of the phase 2 PaTH forward trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026Trial
- Comparative bone histomorphometry effects of combined denosumab and teriparatide vs monotherapy in postmenopausal women with osteoporosis: a randomized controlled trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026Trial
- Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT.The Journal of clinical endocrinology and metabolism · 2020Trial
- Identification of osteoclast-osteoblast coupling factors in humans reveals links between bone and energy metabolism.Nature communications · 2020Trial
- Reduction of Cortical Bone Turnover and Erosion Depth After 2 and 3 Years of Denosumab: Iliac Bone Histomorphometry in the FREEDOM Trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2019Trial
- Building bone in the jaw with denosumab in adult Langerhans cell histiocytosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Exploring bone formation mechanism and pattern during RANKL inhibition in a fibrous dysplasia mouse model.Communications biology · 2026Article
- Article
- Renal function predicts 12-month response to romosozumab readministration after denosumab in women with osteoporosis.Archives of osteoporosis · 2025Article
- Article
- Impact of romosozumab treatment for 24 months after switching from denosumab: three case reports.JBMR plus · 2025Article
- Atypical Femur Fractures-An Analysis of 69 Patients from 15 Years.Journal of clinical medicine · 2025Article
- Long-Term Changes in Parameters of Bone Quality in Kidney Transplant Recipients Treated with Denosumab.Calcified tissue international · 2025Article
- Effectiveness of Sequential Treatment with Zoledronic Acid Following Discontinuation of Denosumab in Osteoporosis: A Narrative Review.Drug design, development and therapy · 2025Review
- Digital twin simulations with a micro-multiphysics agent-based model reveal key drivers of bone loss after denosumab discontinuation.Frontiers in bioengineering and biotechnology · 2025Article
- Targeting the TNF and TNFR superfamilies in autoimmune disease and cancer.Nature reviews. Drug discovery · 2024Review
- Differences in bone histomorphometry between White postmenopausal women with and without atypical femoral fracture after long-term bisphosphonate therapy.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2024Article
- Article
- Reduced osteoprotegerin expression by osteocytes may contribute to rebound resorption after denosumab discontinuation.JCI insight · 2023Article
Corrections and comments
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Authors and funding
10 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Context: Denosumab is a potent antiresorptive agent that reduces fractures in postmenopausal women with osteoporosis. Objective: Determine effects of up to 10 years of denosumab on bone histology, remodeling, and matrix mineralization characteristics. Design and Setting: International, multicenter, randomized, double-blind trial [Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM)] with a long-term open-label extension. Patients: Postmenopausal women with osteoporosis (92 women in FREEDOM, 46 in extension) who provided iliac bone biopsies, including 11 who provided biopsies at multiple time points. Interventions: FREEDOM subjects were randomized 1:1 to subcutaneous denosumab 60 mg or placebo every 6 months for 3 years. Long-term extension subjects continued receiving denosumab, open-label, for 7 additional years. Outcomes: Bone histology, histomorphometry, matrix mineralization. Results: Ten-year denosumab biopsies showed normal histology. Bone histomorphometry indicated normal bone structure and reduced bone remodeling after 10 years of denosumab, similar to levels after 2 and/or 3 and 5 years of denosumab. The degree of mineralization of bone was increased and mineralization heterogeneity was reduced in the denosumab years 2/3 group vs placebo. Changes in these mineralization variables progressed from years 2/3 to year 5 of denosumab, but not thereafter. Conclusions: Denosumab for 2/3, 5, and 10 years was associated with normal histology, low bone remodeling rate, increased matrix mineralization, and lower mineralization heterogeneity compared with placebo. These variables were unchanged from year 5 to year 10. These data, in combination with the maintenance of low fracture rates for up to 10 years as previously reported with denosumab therapy, suggest that strong, prolonged remodeling inhibition does not impair bone strength.
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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.