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

Osteoporosis Clinical Trial

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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306189
• Other study ID #: 20050172
• Secondary ID: NOT APPRICABLE
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2006
• Last updated: June 13, 2013
• Start date: January 2006
• Est. completion date: November 2007

Study information

• Verified date: June 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: November 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• 100 mg AMG 162
100 mg AMG 162 (denosumab) SC every 6 months
• 60 mg AMG 162
60 mg AMG 162 (denosumab) SC every 6 months
• 14 mg AMG 162
14 mg AMG 162 (denosumab) SC every 6 months
• Placebo
Placebo SC every 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Nakamura T, Matsumoto T, Sugimoto T, Shiraki M. Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. Osteoporos Int. 2012 Mar;23(3):1131-40. doi: 10.1007/s00198-011-1786-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	12 months	No

External Links

•   AmgenTrials clinical trials website