Clinical trial NCT02016716: A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
Official title: A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal Osteoporosis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 294
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Detailed description: Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:

* Romosozumab 90 mg/mL
* Placebo 90 mg/mL
* Romosozumab 70 mg/mL
* Placebo 70 mg/mL

After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.

For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.

Eligibility criteria: Inclusion Criteria:

Postmenopausal women with osteoporosis at high risk for fracture defined as

* BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
* a history of fragility fracture or at least 2 other risk factors

Exclusion Criteria:

* BMD T score \< -3.50 at the total hip or femoral neck.
* History of hip fracture.
* History of metabolic or bone disease (except osteoporosis).
* Use of agents affecting bone metabolism.
* Vitamin D insufficiency.
* History of solid organ or bone marrow transplants.
* Hyper- or hypocalcemia.
* Hyper- or hypothyroidism.
* Hyper- or hypoparathyroidism.

Primary outcomes:
measure: Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
timeFrame: Baseline and month 6
Secondary outcomes:
measure: Percent Change From Baseline in Total Hip BMD
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in Femoral Neck BMD
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)
timeFrame: Baseline, month 1, month 3, and month 6
measure: Percent Change From Baseline in Serum C-Telopeptide (CTX)
timeFrame: Baseline, month 1, month 3, and month 6
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Brno
country: Czechia
facility: Research Site
city: Klatovy
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Gliwice
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Swidnik
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: