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NCT02157948 Clinical Trial

A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:
A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02157948
Other study ID # 20120187
Secondary ID 2013-001279-19
Status Completed
Phase Phase 3
First received June 4, 2014
Last updated April 11, 2017
Start date May 2014
Est. completion date July 2015

Study information
Verified date April 2017
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Recruitment information / eligibility
Status Completed
Enrollment 394
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 100 Years
Eligibility Inclusion Criteria:

- Subject has provided informed consent prior to any study-specific activities/procedures

- Ambulatory postmenopausal women.

- Age 55 years or older

- Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.

Exclusion Criteria:

- Administration of osteoporosis treatments or bone active treatments within specific timeframes

- Vitamin D deficiency

- Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)

- Contraindications to denosumab therapy (e.g., hypocalcemia)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Denosumab (CP2)
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
• Denosumab (CP4)
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.

Locations
Country Name City State
Canada Research Site Quebec
Canada Research Site Vancouver British Columbia
Canada Research Site Westmout Quebec
Denmark Research Site Aalborg
Denmark Research Site Ballerup
Denmark Research Site Vejle
Poland Research Site Bialystok
Poland Research Site Gliwice
Poland Research Site Kraków
Poland Research Site Lodz
Poland Research Site Lodz
Poland Research Site Swidnik
Poland Research Site Warszawa
United States Research Site Akron Ohio
United States Research Site Albuquerque New Mexico
United States Research Site Bend Oregon
United States Research Site Bethesda Maryland
United States Research Site Detroit Michigan
United States Research Site Duncansville Pennsylvania
United States Research Site Gainesville Georgia
United States Research Site Lakewood Colorado
United States Research Site Santa Maria California
United States Research Site South Lake Tahoe California

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Other Antidenosumab antibodies Subject incidence of antidenosumab antibodies 12 months
Other Serum denosumab concentrations 12 months
Other Adverse events Subject incidence of adverse events 12 months
Other Standard hematology and serum chemistry tests Changes in laboratory parameters 12 months
Primary Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometry (DXA) at the lumbar spine The primary objective of this study is to evaluate whether the effect on the change in BMD by DXA of lumbar spine at 12 months is comparable between denosumab (CP2) and denosumab (CP4) (60 mg subcutaneously every 6 months). 12 months
Secondary Serum concentration of biomarkers of Bone Turnover (CTX and P1NP) The secondary objective of this study is to evaluate whether the effect on the change in serum CTX and P1NP over 12 months is comparable between denosumab (CP2) and denosumab (CP4) (60 mg subcutaneously every 6 months) 12 months
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Completed NCT00541658 - A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis Phase 3
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Active, not recruiting NCT03720886 - G56W1 in Women With Postmenopausal Osteoporosis Phase 1/Phase 2
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