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Disease

Osteoporosis, Postmenopausal

Late-stage therapeutic developmentEmerging researchSteady momentum
8
Publications
13
Clinical trials
2
Related conditions
1
Related treatments
12
Associated genes
3
Related proteins
2024
Latest publication
Current focus
Estrogen beta biologyTherapeutic developmentMetabolic & lifestyle factors
Latest activity
beta

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

Associations Among Estrogens, the Gut Microbiome and Osteoporosis.

Research2024-11-25Current osteoporosis reports

What's happening now

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

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 1 clinical trial expected to report results, the earliest in Q4 2027.
Upcoming Milestones
Major developments
Major clinical milestoneImportant
Primary completion2026-09-18
Upcoming trial readoutImportant
Results expected Q4 20272026-04-17
Regulatory developmentWorth watching
Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.2026-04-27
Clinical Milestones2View
Results expected 1
Recently completed 1
Regulatory Updates3View
  • 2026-04-27Biosimilar approval — TeriparatideTeriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
  • 2026-03-26Product authorisation ended — Raloxifene hydrochlorideOptruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
  • 2025-11-17Biosimilar approval — 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 timeline5
  • 2026-09-18ClinicalAbaloparatide Added to Ongoing Denosumab vs Continued Denosumab AlonePrimary completion
  • 2026-04-27RegulatoryBiosimilar approval — TeriparatideTeriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
  • 2026-04-17ClinicalCombined Anabolic Therapy StudyResults expected Q4 2027
  • 2026-03-26RegulatoryProduct authorisation ended — Raloxifene hydrochlorideOptruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
  • 2025-11-17RegulatoryBiosimilar approval — 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

Product authorisation ended — Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal… (2026)

Teriparatideapproved

Biosimilar approval — Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women an… (2026)

Denosumabapproved

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

Research-associated treatments

Clinical trials

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

The current development programme across all trial phases.

Clinical programme
13
All trials
4
Active
11
Late-stage
6
Completed
Late-stage studies
Recruiting
Phase 4 · Recruiting · Massachusetts General Hospital
Recently completed

Regulatory timeline

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

Product approvals and authorisations
2026emaBiosimilar approval — Teriparatide· Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. source ↗
2025emaBiosimilar approval — Denosumab· 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 ↗
2025emaBiosimilar approval — Denosumab· Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. Inpostmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hipfractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased riskof fractures. In men with prostate cancer receiving hormone ablation, denosumabsignificantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients atincreased risk of fracture. source ↗
2025emaBiosimilar approval — Denosumab· 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 ↗
2025emaBiosimilar approval — Denosumab· 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 ↗
2025emaBiosimilar approval — Denosumab· 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 ↗
2025emaBiosimilar approval — Denosumab· 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 ↗
2025emaBiosimilar approval — Denosumab· 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 ↗
Other regulatory activity
2026emaProduct authorisation ended — Raloxifene hydrochloride· Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1). source ↗
2020emaProduct authorisation ended — Teriparatide· Qutavina is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. 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

8 papers

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

Publications over time
2002–2024
Most influential

European guidance for the diagnosis and management of osteoporosis in postmenopausal women.

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019 · 1,082 cites

Ten years' experience with alendronate for osteoporosis in postmenopausal women.

The New England journal of medicine · 2004 · 840 cites

The clinician's guide to prevention and treatment of osteoporosis.

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022 · 801 cites

Current Status of the Diagnosis and Management of Osteoporosis.

International journal of molecular sciences · 2022 · 264 cites
Recent publications

Associations Among Estrogens, the Gut Microbiome and Osteoporosis.

Current osteoporosis reports · 2024 · 18 cites

The clinician's guide to prevention and treatment of osteoporosis.

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022 · 801 cites

Current Status of the Diagnosis and Management of Osteoporosis.

International journal of molecular sciences · 2022 · 264 cites

European guidance for the diagnosis and management of osteoporosis in postmenopausal women.

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019 · 1,082 cites
Major themes8
  • Osteoporosis, Postmenopausal5
  • Osteoporosis3
  • Gastrointestinal Microbiome2
  • Bone Density Conservation Agents1
  • Bone Remodeling1
  • Bone Resorption1
  • Estrogens1
  • Osteoporotic Fractures1
Leading journals6
  • Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2
  • BMC musculoskeletal disorders1
  • Current osteoporosis reports1
  • Endocrine reviews1
  • International journal of molecular sciences1
  • The Journal of endocrinology1
Leading researchers8
  • Afanador-Restrepo DF1
  • Aibar-Almazán A1
  • Bone HG1
  • Carcelén-Fraile MDC1
  • Castellote-Caballero Y1
  • Cooper C1
  • Devogelaer JP1
  • Downs RW1
Affiliations (unnormalised)6
  • BioFab i3D-Biofabrication and 3D (Bio) Printing Laboratory1
  • Biosanitary Research Institute of Granada (ibs.GRANADA)1
  • Brigham and Women's Hospital1
  • Centre for Biomedical Research (CIBM)1
  • Centre for Metabolic Bone Diseases1
  • Charles University1

Associated genes

12 matches

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

Disease biology

3 matches

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

2 matches

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

Postmenopausal osteoporosis is a metabolic bone disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15 to 20 years after menopause and is linked to menopause-related estrogen deficiency.

Causes

The supplied grounding identifies menopause-associated estrogen deficiency as the major cause. Review material also describes estrogen deficiency as the key hormonal driver of age-related bone loss in women.

Pathophysiology

The disease is characterized by an imbalance between bone resorption and bone production, with loss of bone density and altered bone remodeling. The grounding also links estrogen deficiency to changes in cytokines and to gut microbiome-related low-grade inflammation and increased gut barrier permeability, which may contribute to bone loss.

Risk factors

Postmenopausal status is the main risk context described in the grounding, especially in women within 15 to 20 years after menopause. Lower estrogen levels are associated with increased risk, and the literature also covers fracture risk assessment in women at risk from osteoporosis.

Current standard of care

Treatment is described at the level of pharmacological and non-pharmacological management. Pharmacological therapy includes anti-resorptive drugs and estrogen-based therapy, while non-pharmacological management includes physical activity, diet, and avoidance of harmful habits such as smoking and high alcohol consumption.

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

Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.

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.