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

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Calcium; Calcium Carbonate; Cholecalciferol; Vitamin D; Vitamins

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