Status:
TERMINATED
A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Osteoporosis
Eligibility:
FEMALE
45-85 years
Phase:
PHASE2
Brief 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.
Detailed Description
Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT00960934
Start Date
October 1 2009
End Date
December 1 2010
Last Update
February 18 2015
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