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Osteoporosis is a systematic skeletal disease characterized by low bone mass, increase of bone fragility and susceptibility to fracture.

Types of Osteoporosis and its causes

  1. Primary osteoporosis(Type I (postmenopausal) or Type II (senile) ):
    1. Type I (postmenopausal): Generally develops in women after menopause when the amount of estrogen in the body greatly decreases. This process leads to an increase in the resorption of bone (the bones loses substance).
    2. Type II (senile): This involves a thinning of both the trabecular bone (the spongy bone inside of the hard cortical bone) and the hard cortical bone. This process often leads to hip and vertebral body (in the spine) fractures.
  2. Secondary osteoporosis: Secondary osteoporosis has the same symptoms as primary osteoporosis. However, it occurs as a result of having certain medical conditions, such as hyperthyroidism or leukemia. It may also occur as a result of taking medications known to cause bone breakdown, such as oral or high-dose inhaled corticosteroids (if used for more than 6 months), too high a dose of thyroid replacement, or aromatase inhibitors (used to treat breast cancer).
  3. Osteogenesis imperfecta: Osteogenesis imperfecta is a rare form of osteoporosis that is present at birth. Osteogenesis imperfecta causes bones to break for no apparent reason.
  4. Idiopathic juvenile osteoporosis:Idiopathic juvenile osteoporosis is rare. It occurs in children between the ages of 8 and 14 or during times of rapid growth. There is no known cause for this type of osteoporosis, in which there is too little bone formation or excessive bone loss.

Incidence and prevalence

Osteoporosis incidence.jpg


  • 1 in 3 women over 50 will suffer a fracture due to osteoporosis; this increases to 1 in 2 over 60.
  • 1 in 5 men over 50 will suffer a fracture due to osteoporosis; this increases to 1 in 3 over 60.
  • Approximately 1.6 million hip fractures occur each year worldwide, the incidence is set to increase to 6.3 million by 2050.
  • The highest risk of hip fractures are seen in Norway, Sweden, Iceland, Denmark and the USA.
  • Currently, there is an increasing incidence of hip fractures in the developed cities in Asia. 1 out of 4 hip fractures occur in Asia and Latin America. This number of hip fractures will increase to 1 in 2 by 2050.
  • In the Middle East, the burden of osteoporosis in the general population is expected to increase and is becoming a heavy financial burden.7
  • The annual incidence rate of osteoporotic fractures in women is greater than the combined incidence rates of heart attack, stroke and breast cancer. (International osteoporosis foundation)


  • 28 million Americans (10 million with osteoporosis; 18 million with low bone mass); eight million American women and 2 million men (NWHIC)(approx 1 in 9 or 10.29% or 28 million people in USA ).
  • Total prevalence rate of osteoporosis in the middle- aged and elderly in China was 16. 1% in 2002. The prevalence rate among males was 11. 5% and among females was 19. 9%.
  • Prevalence increase to 2.2 million in 2006 and 3 million in 2021 in Australia.
  • The prevalence of Khon Kaen (Thai rural area) women has osteporosis in femoral neck and lumbar spine is 19.3% and 24.7% respectively. (International osteoporosis foundation)
S.NO Country/Region Extrapolated Prevalence
1 USA 10 million cases (80% cases are women and 20% cases are men)
2 Australia 2.2 million
3 Middle east 18,603,593
4 Africa 47,233,590
5 Asia 359,862,754
6 Europe 80,590,570

Product Information

Overall categorization of osteoporosis treatments

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Products in market

Generic Brand Current Status Type Company
Alendronate FOSAMAX® Approved by US Postmenopausal Merck
Risedronate Actonel® Approved by US/ES Postmenopausal Sanofi-Aventis/Procter & Gamble
Ibandronate Boniva™ Approved by US Postmenopausal Roche
Etidronate Didronel Off Label   Proctor And Gamble
Zoledronic Acid Aclasta Approved Postmenopausal Novartis
Selective Estrogen Receptor Modulators
Raloxifene Evista® Approved by US Osteoporosis Eli lilly
Hormone Replacement Therapy
Conjugated estrogen Premarin® Approved by US Postmenopausal Wyeth
Conjugated estrogen Cenestin™ Approved by US Postmenopausal Duramed
Esterified estrogens Estratab® Approved by US Postmenopausal Solvay
Esterified estrogens Menesta Approved by US Postmenopausal Monarch
Estradiol Transdermal System Menostar Approved by US Postmenopausal Bayer
Estradiol Transdermal System Vivelle Dot Approved by US Postmenopausal Noven
Estradiol Estrace® Approved by US Postmenopausal Bristol-Myers Squibb
Estradiol Gynodiol Approved by US Postmenopausal Novavax
Tibolone Livifem   Postmenopausal  
Calcitonin Salmon Injection Miacalcin® Approved by US Postmenopausal Novartis
Calcitonin Salmon Nasal Spray Miacalcin® Approved by US Postmenopausal Novartis
Calcitonin Salmon Nasal Spray Fortical® Approved by US Postmenopausal  
Bone Forming Drugs
Teripratide Forteo® Approved by US Osteoporosis Pfizer
Drugs with Complex Mechanisms of Action
Strontium Ranelate Protelos Not approved in USA Postmenopausal osteoporosis Servier
Vitamin D        
Calcium   FDA is considering amending rules so that companies can now claim that calcium and Vitamin D in their food supplements can prevent osteoprorosis in all ages and both sexes   FDA

Product pipeline

Product Pipeline
RANKL Inhibitors
Denosumab Atlantos, Amgen A monoclonal antibody 3
Minodronate (YM529) Astellas Nitrogen containing bisphosphonate    
Calcium Antagonist
423557 Glaxosmithkline   1
423562 Glaxosmithkline   1
Calcilytics (751689) NPS and Glaxosmithkline Calcilytics antagonize calcium receptors on parathyroid glands resulting in a transient release of the bodys own stores of parathyroid hormone (PTH). 1
Parathyroid Hormone
768974 Glaxosmithkline Parathyroid Hormone Agonist 1
Preos (rDNA origin) NPS Recombinant Parathyroid Hormone Registration Filed
PTH1-34 Nastech Intranasal Parathyroid hormone 2
PTH1-34 Novartis, Emisphere Oral Parathyroid hormone 1
PTH Analogs Unigene   2
Cathepsin k Inhibitor
Relacatib (SB-462795) GlaxoSmithkline   1
AAE581 Novartis    
MK-0822 Canadian Institutes of Health Research, Merck   2
Selective Estrogen Receptor Modulators
Bazedoxifene Wyeth, Ligand A Third-Generation Selective Estrogen Receptor Modulator for Treatment of Postmenopausal Osteoporosis  
Lasofoxifene (Oporia) Pfizer,Ligand A Third-Generation Selective Estrogen Receptor Modulator for Treatment of Postmenopausal Osteoporosis NDA
Arzoxifene Eli lilly    
Taromifene (Fareston) Orion    
  Nastech   NDA
Salmon calcitonin Unigene Nasal 3
Salmon calcitonin Unigene Oral 2
Salmon calcitonin (SMC 021) Novartis, Emisphere, Nordic Oral 3
Salmon calcitonin Nobex (Biocon) Oral 3
Vitamin D
ED 71 Bone/ Chugai Activted Vitamin D derivative 3
Doxercalciferol (Hectorol) Bone Care Int. Synthetic Vitamin D  
Nitrates: Research is going on to determine if nitrates can prevent osteoporosis in women.
Isosorbide mononitrate St. Michaels Hospital, Toronto   3
Nitroglycerine Canadian Institutes of Health Research (CIHR)   3
HCT 1026 (NO releasing Derivative of NSAIDs) NicOx SA   2  
Selective Androgen Receptor Modulator (SARM)
LGD-2941 Ligand, TAP   3
LGD-3303 Ligand, TAP   3
Ostarine GTx   2
Intermittent Versus Continuous Androgen Suppression Ontario Cancer Research Network    
Mk 0733 Merck   1
TH0229 Theratechnologies      
c-8500 Merck   2  
c-3578 Merck   2  
apomorphine Ilex Oncology   2  
Genistein Primus Pharmaceuticals, Inc. isoflavones have been shown to interact with animal and human estrogen receptors, causing effects in the body similar to those caused by the hormone estrogen. Available
Soy estrogens (NIAMS)   3
Hesperidin Nestle clinical nutrition   3
Davallia Divaricata National Taiwan University Hospital   1
Atorvaststin  [1]  
Potassium citrate Weill Medical College of Cornell University   4
Phosphorus National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)   3


Hip Protector Hip pads with special underwear with pockets   Childrens Mercy Hospital Kansas City  



Market Information

Prescription Trends in USA
Source: Arch Intern Med. 2004;164:1525-1530
  1988 1990 1992 1994 1996 1998 2000 2002 2003
Patients (Millions) NA 0.6 0.6 0.5 1.2 2 2.6 2.8 3.6
Drugs Prescribed %
Bisphosphonates (total) 1 9 17 14 48 49 54 71 73
Alendronate 0 0 0 0 45 47 48 53 51
Risedronate 0 0 0 0 0 0 4 17 22
Etidronate 1 9 17 14 3 1 1 0 0
Calcium 39 33 33 43 31 26 29 26 24
Calcitonins 5 9 10 13 13 16 15 7 5
Estrogens 35 25 33 27 17 12 8 5 3
SERMs 0 0 0 0 0 9 14 12 12

Clinical Trials

Trial No. Condition Description Intervention Therapy Route of admn Sponsors & Collaborators Phase Date
1 Postmenopausal Osteoporosis Investigate Patient Preference On Dosing In Ibandronate And Risedronate in korean women Ibandronate Drug Oral GlaxoSmithKline Phase IV May-07
2 Osteoporosis
Texture Analysis for Postmenopausal Osteoporosis Alendronate Drug Oral University of Chicago - Mar-07
3 Osteoporosis A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis. SB-751689 Drug Oral GlaxoSmithKline Phase II May-07
4 Osteoporosis Fall prevention program Procedure - - Sint Maartenskliniek
ZonMw: The Netherlands Organisation for Health Research and Development
5 Osteoporosis
High Dosage Vitamin D and Osteoporosis Cholecalciferol Drug Oral University Hospital of North Norway Phase IV Jun-07
6 Osteoporosis Effect of PTH(1-84)or Strontium Ranelate on Bone Formation Measured by Bone Markers Parathyronine hormone Drug Oral Nycomed Phase IV May-07
7 Post-Menopausal Osteoporosis A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis. ibandronate [Bonviva/Boniva] Drug Intravenous Hoffmann-La Roche Phase IV Jul-07
8 Osteoporosis A Study for Patients With Osteoporosis 1.Salmon Calcitonin 2.Teriparatide Drug Nose/intravenous Eli Lilly and Company
Phase III
9 Osteoporosis Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Post Menopausal Women With Osteoporosis Zoledronic acid and alendronate Drug Oral Novartis
Phase III
10 Osteoporosis Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis zoledronic acid Drug Intravenous Novartis
Phase III
11 Osteoporosis Davallia Divaricata BL: The Use of Traditional Chinese Native Medicine for Osteoporosis Gu-Sui-Bu (Davallia Divaricata) Drug National Taiwan University Hospital
Phase I
12 Osteoporosis Dose Ranging Study - Macroflux PTH in Postmenopausal Women With Osteoporosis Macroflux PTH Drug Subcutaneuos The Macroflux Corporation Phase II Jun-07
13 Osteoporosis Fosamax for Childhood Cancer Survivors Alendronate Drug Oral Chinese University of Hong Kong Phase III Oct-06
14 Osteoporosis This study is currently recruiting patients. Parathyroid Hormone (PTH) Drug Subcutaneuos Nycomed - Feb-07
15 Osteoporosis This study is currently recruiting patients. Alendronate with cholecalciferol and Os-Cal with extra D Drug Oral National Institute on Aging (NIA),Glaxosmithkline Phase III May-07
16 Primary Osteoporosis Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis Ibandronic acid Drug Oral Chugai Pharmaceutical Phase III Mar-07
17 Postmenopausal Osteoporosis, Back pain and
Spinal Fracture
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis Teriparatide and risedronate Drug Oral/Subcutaneuos Eli Lilly and Company Phase III Jul-07
18 Osteoporosis BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis. Ibandronate [Bonviva/Boniva] Drug Intravenous Hoffmann-La Roche Phase III Jul-07

Intellectual Property

Search strategy

  • Database/Vendor: Micropat
  • Search scope: US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; Claims
  • Years: Issue/Publication Date: >20051231
  • Search String: ((Osteoporosis OR (bone Near3 regeneration)) AND (treatment))
  • Hits: 1261/982 patents (with/with out family members)
  • Date of search: 14th September 2007

Top players and IPC classes

Top players and IPC.jpeg

Geographical Distribution and Treatment Approaches

Osteoporosis -geographical.jpeg

IP activity and Treatment Approaches

  • Decline in the IP activity during 2006 and 2007 is due 18 months publication delay of patent document.
Osteoporosis -year approach.jpeg


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