An observational follow-up study for: a phase III randomized, placebo-controlled clinical trial to assess the safety and efficacy of odanacatib (MK-0822) to reduce the risk of fracture in osteoporotic postmenopausal women treated with vitamin D and calcium (Protocol 018) (MK-0822-083)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47240
• EU PAS number:
  EUPAS5547
• Study ID:
  47240
• Official title and acronym:
  An observational follow-up study for: a phase III randomized, placebo-controlled clinical trial to assess the safety and efficacy of odanacatib (MK-0822) to reduce the risk of fracture in osteoporotic postmenopausal women treated with vitamin D and calcium (Protocol 018) (MK-0822-083)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Belgium

  Brazil

  Bulgaria

  Chile

  China

  Colombia

  Croatia

  Denmark

  Dominican Republic

  Estonia

  France

  Germany

  Guatemala

  Hong Kong

  India

  Italy

  Japan

  Korea, Republic of

  Latvia

  Lithuania

  Mexico

  New Zealand

  Norway

  Peru

  Philippines

  Poland

  Romania

  Russian Federation

  Serbia

  South Africa

  Spain

  Switzerland

  Taiwan

  Ukraine

  United States
• Study description:
  This is a follow-up study to a placebo-controlled clinical trial (Protocol 018) designed to determine the safety and efficacy, especially fracture-risk reduction, of odanacatib in postmenopausal women with osteoporosis. The purpose of this follow-up study is to collect additional information on specific types of serious adverse events (SAEs) and AEs in those participants who discontinued from the Protocol 018 Base study, completed the Base study but did not enter the double-blind Extension, or discontinued from the double-blind Extension.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Biomelab Barranquilla, Colombia

Study timelines

Date when funding contract was signed

Actual: 19/06/2013

Study start date

Actual: 03/10/2013

Data analysis start date

Planned: 08/07/2016

Actual: 23/07/2016

Date of final study report

Planned: 07/04/2017

Actual: 10/04/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme, LLC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable