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A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: 100 mg AMG 162 (Drug); 60 mg AMG 162 (Drug); 14 mg AMG 162 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.

Clinical Details

Official title: Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects -

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

Primary outcome: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

Eligibility

Minimum age: N/A. Maximum age: 80 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must

be lower than 0. 714 at lumbar spine, 0. 515 at femoral neck, 0. 588 at total hip. - BMD

values must not be lower than 0. 535 at the lumbar spine, 0. 406 at the femoral neck and

0. 478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH

derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational

product. - History of hypocalcemia. - More than two moderate vertebral fractures or any

severe vertebral fracture.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

Starting date: January 2006
Last updated: June 13, 2013

Page last updated: August 23, 2015

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