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Disease

Fractures, Bone

Late-stage therapeutic developmentEmerging researchRising momentum
9
Publications
11
Clinical trials
1
Related conditions
12
Associated genes
1
Related proteins
2025
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Surgery versus conservative management of stable thoracolumbar fracture: the PRESTO feasibility RCT.

Research2021-11-01Health technology assessment (Winchester, England)

Approval: Iasibon (EMA)

Regulatory2011-01-21EMA

Approval: Bondronat (EMA)

Regulatory1996-06-25EMA

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 1 regulatory approval from EMA on record.
  • 1 safety action from EMA issued.
  • 2 clinical trials with recent milestones (1 completed or reporting results).
Major developments
Major clinical milestoneHigh impact
Primary completion2026-09-15
Major trial resultsHigh impact
Results posted2026-03-06
Major safety communicationImportant
Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).2026-03-13
Clinical Milestones2View
Regulatory Updates2View
  • 2026-03-13Market withdrawal — Zoledronic acidPrevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
  • 2025-11-17Approval — DenosumabTreatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Kefdensis significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Activity timeline4
  • 2026-09-15ClinicalNonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic FracturesPrimary completion
  • 2026-03-13RegulatoryMarket withdrawal — Zoledronic acidPrevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
  • 2026-03-06ClinicalAcute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture WoundsResults posted
  • 2025-11-17RegulatoryApproval — DenosumabTreatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Kefdensis significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Denosumabapproved

Approval — Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractur… (2025)

Approval — Prevention of skeletal related events (pathological fractures, spinal compression, radiat… (2014)

Approval — Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological f… (2012)

Clinical trials

10 sponsors · 0 new · 0 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
11
All trials
2
Active
6
Late-stage
6
Completed
Late-stage studies
Recently completed

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2025emaApprovalDenosumab· Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Kefdensis significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). source ↗
2025emaApprovalDenosumab· Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). source ↗
2025emaApprovalDenosumab· Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Izamby significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). source ↗
2025emaApprovalDenosumab· Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, ZADENVI significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). source ↗
2025emaApprovalDenosumab· Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Junod significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Junod significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). source ↗
2025emaApprovalDenosumab· Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). source ↗
2014emaApprovalZoledronic acid· Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). source ↗
2012emaApprovalIbandronic acid· Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour induced hypercalcaemia with or without metastases. Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established. source ↗
Safety updates
2026emaMarket withdrawalZoledronic acid· Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). source ↗
2024emaMarket withdrawalZoledronic acid· Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia. source ↗
2024emaMarket withdrawalZoledronic acid· 4 mg / 5 ml and 4 mg / 100 ml: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 5 mg / 100 ml: Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Paget's disease of the bone in adults. source ↗
2024emaMarket withdrawalIbandronic acid· Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

9 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20012025
Recent publications
Major themes5
  • Fractures, Bone4
  • Osteoporosis3
  • Fracture Healing2
  • Conservative Treatment1
  • Prostheses and Implants1
Leading journals6
  • The New England journal of medicine2
  • Archives of osteoporosis1
  • BioMed research international1
  • Frontiers in immunology1
  • Health technology assessment (Winchester, England)1
  • Injury1
Leading researchers8
  • Adamson J1
  • Ahuja S1
  • Alekseev B1
  • Armstrong DJ1
  • Bone HG1
  • Booth A1
  • Borens O1
  • Bowden J1
Affiliations (unnormalised)6
  • AO Research Institute Davos1
  • Bio5 Institute1
  • Bristol Medical School1
  • Cardiff & Vale University Health Board1
  • Centre for Endocrinology1
  • Division of Infectious Diseases and Hospital Epidemiology1

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

Disease biology

1 match

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Related conditions

1 match

Diseases frequently studied alongside this one. Number shows shared papers.

Disease profile

A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.

Overview

Bone fractures are breaks in bones. The literature grounding here also treats them in the context of fragility fractures and fracture healing, including complications such as non-union and infection after fixation.

Causes

The supplied grounding does not support a specific aetiology for bone fractures beyond the fact that they are breaks in bone. It does note that fracture healing can be complicated by infection after fracture fixation, and that some fractures may fail to heal properly without intervention.

Pathophysiology

Fracture repair is described as a complex, multi-step process involving communication between immune and stromal cells to coordinate tissue repair and regeneration. The inflammatory response is necessary to initiate healing after skeletal trauma, and temporal changes in immune and stromal cell populations shape normal or delayed healing. Bone density and fracture healing are also highlighted as relevant mechanisms, and non-union reflects impaired repair.

Risk factors

The grounding supports osteoporosis-related fragility fracture risk in postmenopausal women and men aged 50 years and older. It also supports increased fracture risk in diabetes, where chronic hyperglycemia and related metabolic changes are associated with osteoporosis and weakened bone formation.

Current standard of care

Management in the supplied grounding is framed around osteoporosis assessment, prevention, and treatment to prevent fragility fractures. The treatment categories mentioned include osteoporosis therapy and fracture prevention strategies, but no specific drug classes are detailed beyond the broader context of osteoporosis management. Infection after fracture fixation is recognized as a complication requiring prevention, diagnosis, and treatment in the surgical setting.

AI-generated summary grounded in MeSH and 5 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Breaks in bones.

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.