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

• Conditions: Osteoporosis; MedDRA version: 12.0Level: LLTClassification code 10031282Term: Osteoporosis

• Registration Number: EUCTR2009-012926-35-DK
• Lead Sponsor: Merck & Co, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 384

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effects of daily oral doses of MK-5442 (2.5, 5, 7.5, 10 or 15 mg) versus placebo for one and two years on areal bone mineral density (aBMD) of the spine, and general safety in postmenopausal women with low-normal BMD or osteoporosis.;Secondary Objective: To assess the effects of daily oral doses of MK-5442 (2.5, 5, 7.5, 10 or 15 mg) versus placebo for one and two years on areal bone mineral density (aBMD) of the hip, volumetric bone mineral density of the spine and hip, biochemical markers of bone turnover, and indices of calcium metabolism in postmenopausal women with low-normal BMD or osteoporosis.;Primary end point(s): Lumbar spine areal BMD – Percent Change from baseline at Month 12 and 24.