A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 1-year base study with a 1-year extension to examine the effects of a new
      experimental medication (odanacatib [MK-0822]) on postmenopausal osteoporosis. This study
      will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different
      doses of odanacatib or to placebo. Measurements performed during the study include: bone
      mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements
      and optional bone biopsies (at the end of 2 years).
    

Detailed description: 
      Study Extension:

      Participants who completed 12 months of the base study and 12 months of the first extension
      were invited to continue in three additional extensions: MK0-822-004-10, which extended the
      study to 36 months, MK-0822-004-20 (NCT00112437) which extended the study to 60 months, and
      MK-0822-004-30 (NCT00112437), which extended the study to 120 months.

        -  In the first extension, participants continued to receive the same treatment they
           received in the 12-month base study.

        -  In the second extension, participants were re-randomized to odanacatib 50 mg OW or
           placebo OW for 12 months.

        -  In the third extension, participants who were initially randomized to odanacatib 3 mg or
           placebo OW in the base study received odanacatib 50 mg weekly in Years 4 and 5; all
           other participants remained on the same treatment they were during Year 3.

        -  In the fourth extension, all participants received odanacatib weekly in Years 6-10.

      Study arms for extensions include only odanacatib 50 mg and placebo for the first two
      extensions and odanacatib 50 mg only for the third extension.

      Extension Studies:

      MK-0822-004-10 (NCT00112437) Extension: Participant has participated in and completed 24
      months of treatment in the base study

      MK-0822-004-20 (NCT00112437) Extension: Participant participated in and completed 36 months
      of treatment in base and extension studies.

      MK-0822-004-30 (NCT00112437) Extension: Participant participated in and completed 60 months
      of treatment in the base and extension studies.
    

Intervention name(s): Odanacatib; Odanacatib; Odanacatib; Odanacatib; Vitamin D3; Calcium Carbonate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): Odanacatib 3 mg, once weekly for 24 months; Odanacatib 10 mg, once weekly for 24 months; Odanacatib 25 mg, once weekly for 24 months; Odanacatib 50 mg, once weekly for 24 months; Vitamin D3, two 2800 IU weekly throughout the study; Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.; Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months
Other intervention name(s): MK-0822; MK-0822; MK-0822; MK-0822
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment