Clinical trial NCT02157948: A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: postmenopausal osteoporosis
osteoporosis
postmenopausal
denosumab
women
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 394
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine BMD
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)
timeFrame: Baseline, month 1, month 6 and month 12
measure: Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
timeFrame: Baseline, month 1, month 6 and month 12
Other outcomes:
Locations:
city: Santa Maria
country: United States
facility: Research Site
state: California
city: South Lake Tahoe
country: United States
facility: Research Site
state: California
city: Lakewood
country: United States
facility: Research Site
state: Colorado
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Bend
country: United States
facility: Research Site
state: Oregon
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Westmout
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Ballerup
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gliwice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Swidnik
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: