Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: odanacatib; placebo to odanacatib
Intervention description: odanacatib 50 mg oral tablet; dose-matched placebo to odanacatib, oral tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: Female
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess to what extent sequential treatment with odanacatib
      results in incremental gains in bone mineral density (BMD) over time in female participants
      who have received at least 3 years of bisphosphonate therapy. It was hypothesized that
      odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.
    

Eligibility criteria:

        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.