A Dose-Ranging Study of MK5442 in Postmenopausal Women With Osteoporosis
Tracking InformationStart Date ICMJE | October 2009 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
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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 ]
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00960934 on ClinicalTrials.gov Archive Site |
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Descriptive InformationBrief Title ICMJE | A Dose-Ranging Study of MK5442 in Postmenopausal Women With Osteoporosis |
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Official Title ICMJE | A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK5442 in the Treatment of Postmenopausal Women With Osteoporosis |
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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. |
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Detailed Description | |
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Study Phase | Phase II |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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Condition ICMJE | Osteoporosis |
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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.
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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
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Recruitment InformationEstimated Enrollment ICMJE | 480 |
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Estimated Completion Date | March 2011 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
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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
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Gender | Female |
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Ages | 45 Years to 85 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Toll Free Number | 1-888-577-8839 | | |
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Location Countries ICMJE | United States, Denmark, Norway, Russian Federation, South Africa, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT00960934 |
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Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
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Study ID Numbers ICMJE | 2009_631, MK5442-001 |
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Study Sponsor ICMJE | Merck |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Medical Monitor | Merck | |
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Information Provided By | Merck |
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