Clinical trial NCT01796301: An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Official title: An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal Osteoporosis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 436
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 primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women, aged ≥ 55 to ≤ 90.
* Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
* BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
* History of nonvertebral fracture after age 50, or vertebral fracture.

Exclusion Criteria:

* Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids:
* History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
* Vitamin D insufficiency, defined as 25 (OH) vitamin D levels \< 20 ng/mL, as determined by the central laboratory.
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism

Primary outcomes:
measure: Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)
timeFrame: Baseline, month 6 and month 12
Secondary outcomes:
measure: Percent Change From Baseline in Total Hip BMD at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in Total Hip BMD at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Femoral Neck BMD at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in Femoral Neck BMD at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 12
timeFrame: Baseline and month 12
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Research Site
state: Córdoba
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege 1
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Quebec
country: Canada
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlántico
city: Brno
country: Czechia
facility: Research Site
city: Ostrava 1
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 11 - Chodov
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Aarhus C
country: Denmark
facility: Research Site
city: Ballerup
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Hillerød
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Granada
country: Spain
facility: Research Site
state: Andalucía
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: LHospitalet de Llobregat
country: Spain
facility: Research Site
state: Cataluña
city: Pozuelo de Alarcon
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Chorley
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Sidcup
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, Engelke K, Finkelstein JS, Genant HK, Goemaere S, Hyldstrup L, Jodar-Gimeno E, Keaveny TM, Kendler D, Lakatos P, Maddox J, Malouf J, Massari FE, Molina JF, Ulla MR, Grauer A. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017 Sep 30;390(10102):1585-1594. doi: 10.1016/S0140-6736(17)31613-6. Epub 2017 Jul 26.
citation: Takada J, Dinavahi R, Miyauchi A, Hamaya E, Hirama T, Libanati C, Nakamura Y, Milmont CE, Grauer A. Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial. J Bone Miner Metab. 2020 May;38(3):310-315. doi: 10.1007/s00774-019-01057-1. Epub 2019 Nov 9.