A Dose-Ranging Study of MK5442 in Postmenopausal Women With Osteoporosis


Tracking Information

Start Date  ICMJEOctober 2009
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 17, 2009)
  • Percent change from baseline in lumbar spine areal bone mineral density (BMD) at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Number (percent) of patients with total serum calcium levels outside the pre-defined limits of change [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Number (percent) of patients with albumin-corrected calcium levels outside the pre-defined limits of change [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Number (percent) of patients with kidney stones [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Number (percent) of patients with bone neoplasms [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00960934 on ClinicalTrials.gov Archive Site

Descriptive Information

Brief Title  ICMJEA Dose-Ranging Study of MK5442 in Postmenopausal Women With Osteoporosis
Official Title  ICMJEA Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK5442 in the Treatment of Postmenopausal Women With Osteoporosis
Brief Summary

This study will identify an appropriate dose of MK5442 that will produce an osteoanabolic (bone-building) effect without causing high blood calcium levels.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition  ICMJEOsteoporosis
Intervention  ICMJE
  • Drug: MK5442
    MK5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for 24 months. There will be a 2-week period during which all patients will receive placebo.
  • Drug: Comparator: Placebo
    Matching placebo to MK5442 once daily for 24 months.
  • Dietary Supplement: Comparator: Vitamin D3
    Vitamin D3, two 400 IU tablets daily throughout the study.
  • Dietary Supplement: Comparator: calcium carbonate
    Patients who have a calcium intake less than 1200 mg/day will receive a daily 500 mg calcium supplement throughout the study. A Dietary Calcium Questionnaire will be repeated at Month 12 if the patient indicates at that time that her diet has changed significantly over the past year with respect to milk products.
Study Arms / Comparison Groups
  • 1: Experimental
    MK5442 2.5 mg
    Interventions:
    • Drug: MK5442
    • Dietary Supplement: Comparator: Vitamin D3
    • Dietary Supplement: Comparator: calcium carbonate
  • 2: Experimental
    MK5442 5 mg
    Interventions:
    • Drug: MK5442
    • Dietary Supplement: Comparator: Vitamin D3
    • Dietary Supplement: Comparator: calcium carbonate
  • 3: Experimental
    MK5442 7.5 mg
    Interventions:
    • Drug: MK5442
    • Dietary Supplement: Comparator: Vitamin D3
    • Dietary Supplement: Comparator: calcium carbonate
  • 4: Experimental
    MK5442 10 mg
    Interventions:
    • Drug: MK5442
    • Dietary Supplement: Comparator: Vitamin D3
    • Dietary Supplement: Comparator: calcium carbonate
  • 5: Experimental
    MK5442 15 mg
    Interventions:
    • Drug: MK5442
    • Dietary Supplement: Comparator: Vitamin D3
    • Dietary Supplement: Comparator: calcium carbonate
  • 6: Placebo Comparator
    Placebo
    Interventions:
    • Drug: Comparator: Placebo
    • Dietary Supplement: Comparator: Vitamin D3
    • Dietary Supplement: Comparator: calcium carbonate

Recruitment Information

Estimated Enrollment  ICMJE480
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has been postmenopausal for at least 5 years
  • Patient has no history of fragility fracture, unless she is unwilling to take or is not a candidate for marketed osteoporosis therapy
  • Patient agrees not to use medications for osteoporosis except that provided by the study
  • The patient has an areal 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. Patients unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal BMD T-scores < -3.5

Exclusion Criteria:

  • Patient has used oral bisphosphonates in the 6 months prior to screening, for more than 3 months in the past 2 years, or lifetime use for more than 6 months total
  • Patient has used IV bisphosphonates, strontium, or growth hormone at any time
  • Patient is currently using phenytoin, raloxifene, or heparin
  • Patient is using pioglitazone or rosiglitazone at screening
  • Patient has had prior neck surgery with a total thyroidectomy
  • Patient is known to be HIV-positive
  • Patient has had cancer within 5 years of screening, except for certain skin or cervical cancers
  • Patient currently uses any illicit drug and/or has a history of alcohol abuse
GenderFemale
Ages45 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Denmark,   Norway,   Russian Federation,   South Africa,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00960934
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2009_631, MK5442-001
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck