A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Odanacatib; Odanacatib; Odanacatib; Odanacatib; Vitamin D3; Calcium Carbonate; Placebo
Intervention description: 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
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 399.0
Sex: Female
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal for 5 or more years, defined as no menses for at least 5 years OR at
             least 5 years status post bilateral oophorectomy

          -  Bone mineral density T-score at the hip or spine of -2.0 or less

          -  Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar
             spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to
             L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative
             joint disease, and sequelae of orthopedic procedures that result in anatomy that is
             unsuitable for accurate bone densitometry must be absent from the lumbar spine.)

          -  At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic
             procedures)

          -  In a state of general health allowing for successful completion of the trial

          -  Agreement to not use any medications to treat osteoporosis during the study

        Exclusion Criteria:

          -  History of prior osteoporotic fracture (unless declined treatment with or was
             ineligible for osteoporosis therapy)

          -  Past treatment with osteoporosis medications, steroids, hormone replacement, as well
             as various other medications that affect bone may be exclusionary. (Different
             exclusion criteria apply to each bone active drug. For example, any prior use of
             intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone
             replacement for several years is permitted if it has not occurred within the past 6
             months. Please ask the study doctor for details)

          -  Significant clinical or laboratory abnormalities at the screening visit for the study
             that, in the opinion of the investigator, could complicate interpretation of the study
             results or pose additional risk to the patient (for example, patients who are
             non-ambulatory should be excluded for this reason)