Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)

Inclusion Criteria:

- Postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5
years post bilateral oophorectomy).

- Prior or current treatment with oral bisphosphonate therapy (i.e., alendronate,
risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years.

- BMD T-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and >-3.5
as assessed by dual-energy X-ray absorptiometry (DXA) without a history of a prior
fragility fracture. For participants with a history of a prior fragility fracture
(except hip fracture), BMD T-score can be ≤-1.5 and >-3.5 at any hip site.

- Serum 25-hydroxyvitamin D level of ≥20 and ≤60 ng/mL within 90 days of the time of
randomization.

Exclusion Criteria:

- Evidence of a metabolic bone disorder other than osteopenia or osteoporosis

- History or current evidence of hip fracture.

- History of malignancy ≤5 years prior to signing informed consent, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical
cancer.

- Active parathyroid disease. Participant with a documented history of parathyroid
disease can be considered for inclusion if she has normal parathyroid hormone (PTH)
at screening.

- History of thyroid disease not adequately controlled by medication.

- Current treatment with anti-seizure medication, with indices of calcium metabolism
not within normal limits.

- Prior treatment with strontium-containing products; intravenous bisphosphonates;
cathepsin K inhibitors; RANK ligand inhibitors; fluoride treatment at a dose greater
than 1 mg/day for more than 2 weeks.

- Use of following medications within the 6 months prior to the screening visit:
activated vitamin D; estrogen, with or without progestin, at a dose high enough to
have systemic effects; raloxifene or other selective estrogen receptor modulator
(SERM), tibolone or any aromatase inhibitor; sub-cutaneous calcitonin (Note: use of
intranasal calcitonin is allowed at any time); anabolic steroid; PTH (1-34 or 1-84);
growth hormone; systemic glucocorticoids (≥5 mg/day of prednisone or equivalent) for
more than 2 weeks; cyclosporine for more than 2 weeks.

- Concurrent use of cancer chemotherapy or heparin; protease inhibitors for human
immunodeficiency virus (HIV) treatment; and vitamin A (excluding beta carotene)
>10,000 IU daily, unless willing to discontinue this dose during the study.

- Current treatment with cytochrome P450 3A4 (CYP3A4) inducers or treatment with CYP3A4
inducer within 4 weeks of screening.