MK5442 in the Treatment of Osteoporosis in Postmenopausal WomenPreviously Treated With an Oral Bisphosphonate (MK-5442-012 AM1)

Phase 2

Completed

Conditions: Health Condition 1: M810- Age-related osteoporosis without current pathological fractureHealth Condition 2: null- Postmenopausal Osteoporosis

Registration Number: CTRI/2010/091/000258

Lead Sponsor: Merck Sharp and Dohme

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 526

Inclusion Criteria

Patient has been taking an oral bisphosphonate for osteoporosis for at least 3 years within the past 4 years, and the bisphosphonate must have been alendronate for the most recent 12 months, and is currently taking alendronate.

Patient has a BMD T-score that is less than or equal to -1.5 at one or more of the following 4 BMD sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is greater than or equal to -4.0, AND a history of at least one fragility fracture, OR, an aBMD T-score that is less than or equal to -2.5 at one or more of the following 4 BMD sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is greater than or equal to -4.0

Patient has been postmenopausal for at least 5 years

Exclusion Criteria

- Is unable to have dual-emission X-ray absorptiometry (DXA) performed due to obesity

- Has received intravenous (IV) bisphosphonates, fluoride treatment at a dose 1 mg/day for more than 2 weeks, strontium, growth hormone, a cathepsin K inhibitor, or a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor at any time in the past

- Has received 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

- Has used 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

- Is taking more than 10,000 IU vitamin A daily or more than 5,000 IU vitamin D daily

- Has had a total thyroidectomy

- Has any history of Pagets disease

- Is HIV positive

- Has a history of cancer in the last 5 years, except certain skin or cervical cancers

- Has a history of major upper gastrointestinal mucosal erosive disease

- Is unable to adhere to dosing instructions for alendronate in regard to fasting and positioning

- Is not ambulatory

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in lumbar spine areal bone mineral density (BMD) compared to continued alendronate therapy at Month 12Timepoint: Baseline and Month 12

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in total hip, femoral neck, trochanter, total body, and 1/3 distal forearm areal bone mineral density (BMD) at Month 12Timepoint: Baseline and Month 12