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

Phase 2
45 Years
85 Years
Not Enrolling

Thank you

Trial Information

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)

Outcome Description:

Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).

Outcome Time Frame:

Baseline (BL) and Month 6

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

December 2010

Related Keywords:

  • Osteoporosis
  • Osteoporosis
  • Postmenopausal
  • MK-5442
  • Osteoporosis