Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 399
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Odanacatib intervention 2: Odanacatib intervention 3: Odanacatib intervention 4: Odanacatib intervention 5: Vitamin D3 intervention 6: Calcium Carbonate intervention 7: Placebo
Intervention descriptions: intervention 1: Odanacatib 3 mg, once weekly for 24 months intervention 2: Odanacatib 10 mg, once weekly for 24 months intervention 3: Odanacatib 25 mg, once weekly for 24 months intervention 4: Odanacatib 50 mg, once weekly for 24 months intervention 5: Vitamin D3, two 2800 IU weekly throughout the study intervention 6: Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium. intervention 7: Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months

Protocol document: