Postmenopausal Osteoporosis

19
Pipeline Programs
12
Companies
31
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
0
1
0
11
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
375%
Peptide
125%
+ 19 programs with unclassified modality

On Market (1)

Approved therapies currently available

Radius Health
TYMLOSApproved
abaloparatide
Radius Health
Parathyroid Hormone-Related Peptide Analog [EPC]subcutaneous2017

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Roche
RocheSTAVANGER NORWAY, Norway
4 programs
1
ibandronate [Bonviva/Boniva]Phase 41 trial
Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in PakistanN/A1 trial
alendronateN/A1 trial
ibandronate [Bonviva/Boniva]N/A5 trials
Active Trials
NCT02422069Completed624Est. Dec 2011
NCT01128257Completed6,054Est. Dec 2011
NCT01290094Completed41Est. Jul 2014
+5 more trials
Radius Health
Radius HealthMA - Boston
3 programs
1
2
1
AlendronatePhase 31 trial
abaloparatidePhase 3Peptide1 trial
abaloparatide-sMTSPhase 11 trial
Active Trials
NCT04366726CompletedEst. May 2019
NCT01657162CompletedEst. Oct 2016
NCT04064411CompletedEst. Nov 2021
Amgen
AmgenTHOUSAND OAKS, CA
6 programs
1
1
3
RomosozumabPhase 3Monoclonal Antibody1 trial
RomozosumabPhase 3Monoclonal Antibody1 trial
alendronatePhase 31 trial
AlendronatePhase 21 trial
DenosumabPhase 1Monoclonal Antibody1 trial
+1 more programs
Active Trials
NCT03970902Completed239Est. Apr 2022
NCT01221727Completed30Est. Jul 2011
NCT00293813Completed247Est. Aug 2008
+3 more trials
Enzene Biosciences
Enzene BiosciencesIndia - Pune
1 program
1
ENZ215Phase 31 trial
Active Trials
NCT05405725Completed504Est. Jul 2024
Fresenius Kabi
Fresenius KabiGermany - Bad Homburg
1 program
1
FKS518Phase 31 trial
Active Trials
NCT04934072Completed553Est. Aug 2023
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
1
QL1206Phase 31 trial
Active Trials
NCT04128163UnknownEst. Dec 2021
Gedeon Richter
Gedeon RichterHungary - Budapest
1 program
1
RGB-14-PPhase 31 trial
Active Trials
NCT05087030Completed473Est. Nov 2023
E
EisaiChina - Liaoning
1 program
1
menatetranonePhase 31 trial
Active Trials
NCT00165698Completed240Est. Jul 2007
Sanofi
SanofiPARIS, France
1 program
1
risedronatePhase 31 trial
Active Trials
NCT00577421Completed32Est. Jan 2006
Novartis
NovartisBASEL, Switzerland
2 programs
2
Oral salmon calcitoninPhase 11 trial
PTH134Phase 11 trial
Active Trials
NCT00411125Completed86Est. Nov 2006
NCT00676312Completed32
Pfizer
PfizerNEW YORK, NY
1 program
1
Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mgPhase 11 trial
Active Trials
NCT00381251CompletedEst. Jan 2007
CP
Chugai PharmaJapan - Tokyo
1 program
Eldecalcitol soft capsulesN/A1 trial
Active Trials
NCT05433207Unknown1,000Est. Jan 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Rocheibandronate [Bonviva/Boniva]
Rocheibandronate [Bonviva/Boniva]
Rocheibandronate [Bonviva/Boniva]
Rocheibandronate [Bonviva/Boniva]
Rocheibandronate [Bonviva/Boniva]
Rocheibandronate [Bonviva/Boniva]
Rocheibandronate [Bonviva/Boniva]
Enzene BiosciencesENZ215
Gedeon RichterRGB-14-P
Fresenius KabiFKS518
Radius Healthabaloparatide
Qilu PharmaceuticalQL1206
AmgenRomosozumab
AmgenRomozosumab
Radius HealthAlendronate

Showing 15 of 31 trials with date data

Clinical Trials (31)

Total enrollment: 16,956 patients across 31 trials

NCT00503113Rocheibandronate [Bonviva/Boniva]

A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

Start: Jul 2007Est. completion: Apr 2010801 patients
Phase 4Completed
NCT00545090Rocheibandronate [Bonviva/Boniva]

ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Start: Aug 2006Est. completion: Jun 2008561 patients
Phase 4Completed
NCT00545480Rocheibandronate [Bonviva/Boniva]

SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.

Start: Jul 2006Est. completion: Mar 2009596 patients
Phase 4Completed
NCT00377234Rocheibandronate [Bonviva/Boniva]

A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

Start: May 2006Est. completion: Aug 2008356 patients
Phase 4Completed
NCT00545909Rocheibandronate [Bonviva/Boniva]

BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

Start: Mar 2006Est. completion: Aug 2008585 patients
Phase 4Completed
NCT00551174Rocheibandronate [Bonviva/Boniva]

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

Start: Oct 2004Est. completion: Nov 2008781 patients
Phase 4Completed
NCT00081653Rocheibandronate [Bonviva/Boniva]

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Start: May 2004Est. completion: May 2008719 patients
Phase 4Completed

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

Start: Jul 2022Est. completion: Jul 2024504 patients
Phase 3Completed

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

Start: Sep 2021Est. completion: Nov 2023473 patients
Phase 3Completed

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Start: Jun 2021Est. completion: Aug 2023553 patients
Phase 3Completed

Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

Start: Aug 2019Est. completion: Nov 2021
Phase 3Completed

Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk

Start: Jun 2019Est. completion: Dec 2021
Phase 3Unknown
NCT02791516AmgenRomosozumab

A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis

Start: Jan 2017Est. completion: Dec 201867 patients
Phase 3Completed
NCT01796301AmgenRomozosumab

An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

Start: Jan 2013Est. completion: May 2015436 patients
Phase 3Completed

Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

Start: Nov 2012Est. completion: Oct 2016
Phase 3Completed
NCT01290094Rocheibandronate [Bonviva/Boniva]

A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

Start: Apr 2011Est. completion: Jul 201441 patients
Phase 3Completed
NCT00377819Amgenalendronate

Study of Transitioning From Alendronate to Denosumab

Start: Sep 2006Est. completion: Jul 2008504 patients
Phase 3Completed
NCT00165698Eisaimenatetranone

Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

Start: May 2005Est. completion: Jul 2007240 patients
Phase 3Completed

Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

Start: Jun 2003Est. completion: Jan 200632 patients
Phase 3Completed
NCT00048074Rocheibandronate [Bonviva/Boniva]

DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

Start: Jun 2002Est. completion: May 20051,395 patients
Phase 3Completed
NCT00293813AmgenAlendronate

A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

Start: May 2006Est. completion: Aug 2008247 patients
Phase 2Completed
NCT04366726Radius Healthabaloparatide-sMTS

Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)

Start: Apr 2019Est. completion: May 2019
Phase 1Completed

The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam

Start: Nov 2010Est. completion: Jul 201130 patients
Phase 1Completed

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects

Start: May 200832 patients
Phase 1Completed
NCT00381251PfizerFormulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg

Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.

Start: Sep 2006Est. completion: Jan 2007
Phase 1Completed
NCT00411125NovartisOral salmon calcitonin

Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

Start: Aug 2006Est. completion: Nov 200686 patients
Phase 1Completed
NCT05433207Chugai PharmaEldecalcitol soft capsules

Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis

Start: Aug 2022Est. completion: Jan 20251,000 patients
N/AUnknown
NCT03970902AmgenIntegrated Osteoporosis Care

Quality of Life in Postmenopausal Women With Osteoporosis

Start: Jul 2019Est. completion: Apr 2022239 patients
N/ACompleted
NCT02422069RocheStudy of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan

Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan

Start: Apr 2010Est. completion: Dec 2011624 patients
N/ACompleted
NCT01128257Rochealendronate

A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis

Start: Apr 2010Est. completion: Dec 20116,054 patients
N/ACompleted
NCT00493532Rocheibandronate [Bonviva/Boniva]

A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Start: Jun 2007Est. completion: Dec 2010
N/ANo Longer Available

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

11 late-stage (Phase 3) programs — potential near-term approvals
12 companies competing in this space