EUCTR2009-012926-35-DK
Active, not recruiting
Not Applicable
A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women with Osteoporosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Merck & Co, Inc.
- Enrollment
- 384
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consenting postmenopausal women (\=5 years since menopause) 45 to 85 years of age, with low bone density who have at screening, an areal BMD T\-score that is \=\-2\.5 at one or more of the following 4 BMD sites; lumbar spine, femoral neck, trochanter, and total hip, measured at screening by the central imaging vendor, and BMD T\-scores \= \-3\.5 at all of these 4 BMD sites, with or without a prior vertebral or non\-vertebral fragility fracture. The patient has no fragility fracture (including any vertebral fracture), documented by medical record, or detected on the screening spine radiographs read locally, unless the patient is unwilling to take, or is not a candidate for marketed osteoporosis therapy. The patient has no increased risk of bone cancer due to any reason, such as a history of skeletal malignancy at any time, or a history of therapeutic irradiation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •The patient has prior use with any agents with action on bone as defined in the protocol. Use of anti\-osteoporotic agents during the study (other than the supplied calcium and vitamin D3\) is exclusionary. The patient anticipates use of potent inhibitors or potent inducers of CYP3A4\. The patient has significant clinical or laboratory abnormalities at the screening visit for the study including but not limited to other metabolic bone disorders, indices of calcium and mineral homeostasis, hepatic, and renal laboratory abnormalities.
Outcomes
Primary Outcomes
Not specified
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