A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: MK-5442; Placebo; Vitamin D3; Calcium carbonate
Intervention description: MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.; Dose-matched oral placebo to MK-5442; Vitamin D3, two 400 IU tablets daily throughout the study.; Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.
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: 383.0
Sex: Female
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoporosis; Postmenopausal; MK-5442

Summary:

      The purpose of this study was to identify an appropriate dose of

      MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal
      women with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal for at least 5 years

          -  No history of fragility fracture, unless participant is not willing to take marketed
             osteoporosis therapy or is not a candidate for marketed osteoporosis therapy

          -  Agrees not to use medications for osteoporosis except medications associated with the
             study

          -  Areal bone mineral density (BMD) T-score <-2.5 at one or more of the following 4 BMD
             sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD
             sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy
             may have one or more areal BMD T-scores of < -3.5

        Exclusion Criteria:

          -  Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie,
             weight >250 lbs)

          -  Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3
             months in the past 2 years, or lifetime use of more than 6 months

          -  Use of intravenous bisphosphonates, strontium, or growth hormone at any time

          -  Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within
             6 months prior to Visit 1

          -  Use of pioglitazone or rosiglitazone at study screening

          -  Use of estrogen ± progestin, in any form other than vaginal or topical application,
             for 6 months prior to Study Visit 1

          -  Prior total thyroidectomy

          -  Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome
             (AIDS)-related illness

          -  History of malignant cancer within 5 years of study screening, except for certain skin
             or cervical cancers

          -  History of Paget's disease and/or kidney stones

          -  An active user of any illicit drug

          -  History of or active alcohol abuse

          -  Participated in an investigational drug study within the past 30 days