MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)
Condition: Osteoporosis; Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: MK-5442; Placebo to MK-5442; Alendronate Sodium; Vitamin D3; Calcium carbonate; Placebo to Alendronate
Intervention description: MK-5442 tablets (randomized to a dose of 5, 7.5, 10 or 15 mg) taken orally, once-daily, for 12 months; Matching placebo to MK-5442 taken orally, once-daily, for 12 months; Alendronate tablets 70 mg, taken orally, once-weekly, for 12 months; Vitamin D3 (cholecalciferol) administered orally, at a dose of 5600 IU (two tablets, 2800 IU each), once-weekly for 12 months; Participants who qualify (those who have a calcium intake of less than 1200 mg/day) will receive oral supplemental calcium carbonate, at a dose of either 400 mg or 500 mg, once-daily, for 12 months; Placebo to alendronate once-weekly for 12 months
Intervention MeSH terms: Vitamin D; Cholecalciferol; Alendronate; Calcium Carbonate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 526.0
Sex: Female
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be
      achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been
      receiving oral bisphosphonate therapy for at least 3 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Taking oral bisphosphonate treatment for osteoporosis for at least 3 of the past 4
             years. At present, and for the past 12 months, treated with alendronate

          -  Bone Mineral Density (BMD) T-score that is ≤ -1.5 at one or more of the following
             anatomic sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD
             T-score at all of these sites that is ≥ -4.0, AND a history of at least one fragility
             fracture, OR, a BMD T-score that is ≤ -2.5 at one or more of the following anatomic
             sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all
             of these sites that is ≥ -4.0

          -  Postmenopausal for at least 5 years

        Exclusion Criteria:

          -  Obesity (ie, weight greater than 250 pounds) that prohibits the use of dual-emission
             X-ray absorptiometry (DXA)

          -  Received intravenous (IV) bisphosphonates, fluoride treatment at a dose >1 mg/day for
             more than 2 weeks, strontium, growth hormone, a cathepsin K (CTSK) inhibitor, or a
             receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor at any time in
             the past

          -  Use of oral bisphosphonates other than alendronate in the last 12 months, parathyroid
             hormone (PTH) in the last 24 months, cyclosporin for more than 2 weeks in the last 6
             months, heparin in the last 2 weeks, or anabolic steroids or glucocorticoids for more
             than 2 weeks in the past 6 months

          -  Use of estrogen with or without progestin or a selective estrogen receptor modulator
             (SERM) in the last 6 months or calcitonin in the last 30 days

          -  Has used pioglitazone hydrochloride or rosiglitazone hydrochloride in the last 6
             months

          -  Taking more than 10,000 International Units (IU) vitamin A daily or more than 5,000 IU
             vitamin D daily

          -  Has had a total thyroidectomy

          -  History of Paget's disease

          -  Has human immunodeficiency virus (HIV)

          -  History of cancer in the last 5 years, except certain skin or cervical cancers

          -  History of major upper gastrointestinal (GI) mucosal erosive disease

          -  Unable to adhere to dosing instructions for alendronate in regard to fasting and
             positioning

          -  Not ambulatory