A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)

A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women With Osteoporosis

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.

Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.

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