Status:
COMPLETED
MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Osteoporosis
Postmenopausal Osteoporosis
Eligibility:
FEMALE
45-85 years
Phase:
PHASE2
Brief Summary
This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been receiving oral bisp...
Detailed Description
The study was originally planned for a duration of 2 years and included efficacy analysis of a 15 mg MK-5442 treatment arm. Amendment 1 of the protocol eliminated the 2nd year of the study as well the...
Eligibility Criteria
Inclusion
- Taking oral bisphosphonate treatment for osteoporosis for at least 3 of the past 4 years. At present, and for the past 12 months, treated with alendronate
- Bone Mineral Density (BMD) T-score that is ≤ -1.5 at one or more of the following anatomic sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is ≥ -4.0, AND a history of at least one fragility fracture, OR, a BMD T-score that is ≤ -2.5 at one or more of the following anatomic sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is ≥ -4.0
- Postmenopausal for at least 5 years
Exclusion
- Obesity (ie, weight greater than 250 pounds) that prohibits the use of dual-emission X-ray absorptiometry (DXA)
- Received intravenous (IV) bisphosphonates, fluoride treatment at a dose \>1 mg/day for more than 2 weeks, strontium, growth hormone, a cathepsin K (CTSK) inhibitor, or a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor at any time in the past
- Use of oral bisphosphonates other than alendronate in the last 12 months, parathyroid hormone (PTH) in the last 24 months, cyclosporin for more than 2 weeks in the last 6 months, heparin in the last 2 weeks, or anabolic steroids or glucocorticoids for more than 2 weeks in the past 6 months
- Use of estrogen with or without progestin or a selective estrogen receptor modulator (SERM) in the last 6 months or calcitonin in the last 30 days
- Has used pioglitazone hydrochloride or rosiglitazone hydrochloride in the last 6 months
- Taking more than 10,000 International Units (IU) vitamin A daily or more than 5,000 IU vitamin D daily
- Has had a total thyroidectomy
- History of Paget's disease
- Has human immunodeficiency virus (HIV)
- History of cancer in the last 5 years, except certain skin or cervical cancers
- History of major upper gastrointestinal (GI) mucosal erosive disease
- Unable to adhere to dosing instructions for alendronate in regard to fasting and positioning
- Not ambulatory
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT00996801
Start Date
November 1 2009
End Date
June 1 2011
Last Update
January 22 2016
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