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Odanacatib for Postmenopausal Osteoporosis

Source agency:

CADTH

Date of Submission:

13/08/2012

Date of Printing:

19/05/2013

Disclaimer:

This report is work in progress and should not be used for external distribution without permission from the originating agency. Users should be aware that reports are based on information available at the time of research and often on a limited literature search.

Technology, Company & Licensing

Technology name:

Odanacatib

Technology - description:

Odanacatib belongs to a new class of osteoporosis drugs designed to block cathepsin K, a lysosomal protease that plays a role in the function of osteoclasts. By inhibiting cathepsin K, odanacatib reduces bone resorption by osteoclasts.

Company or developer:

Merck & Co., Inc

Reason for database entry:

It represents a potentially innovative alternative to existing therapies

Technology - stage in early warning process:

Prioritised for assessment

Technology - stage of development:

Investigational - phase III

Licensing, reimbursement and other approval:

Odanacatib is not currently licensed for sale in Canada or the United States.

Technology - type(s):

Drug

Technology - use(s):

Therapeutic

Patient Indication & Setting

Patient indications:

postmenopausal osteoporosis

Disease description and associated mortality and morbidity:

Postmenopausal osteoporosis occurs when a fall in estrogen levels causes the rate of bone resorption to increase, resulting in excessive bone loss.1 Osteoporosis affects more than 1.5 million Canadians.18 The prevalence of osteoporosis has been estimated to increase from 6% of women aged 50 to 59 years, to more than 40% of women aged 80 years and older.18 Fragility fractures represent 80% of all fractures in menopausal women older than 50 years.19 Fractures increase the risk of chronic pain, bone deformity, depression, long-term disability, and mortality.

Number of Patients:

 

Technology - specialities(s):

None

Technology - setting(s):

None

Setting - further information:

 

Impact

Alternative and/or complementary technology:

 

Current Technology:

 

Health Impact:

 

Diffusion:

 

Cost, infrastructure and economic consequences:

 

Ethical, social, legal, political and cultural impact:

 

Evidence & Policy

Clinical evidence and safety:

One phase 2 trial33 and its extension studies34-37 assessing odanacatib for the treatment of postmenopausal osteoporosis was identified. The results are summarized in Table 1. Two phase 2 trials38,39 and one phase 3 trial40 evaluating the effect of odanacatib on bone mineral density in postmenopausal women have been completed, but results have not yet been published. A phase 3 trial investigating the effect of odanacatib on bone mineral density in osteoporotic postmenopausal women previously treated with alendronate has been planned, but is not yet open for participant recruitment.41 An ongoing phase 3 trial is evaluating the safety and efficacy of odanacatib for the prevention of fractures in postmenopausal women with osteoporosis.

Economic evaluation:

 

Ongoing research:

 

Ongoing or planned HTA:

 

Web link:

http://www.cadth.ca/media/pdf/EH0004-000_odanacatib_bulletin_e.pdf

References and sources:

 

Notes: